ABSORICA Capsule Ref.[50736] Active ingredients: Isotretinoin

Source: FDA, National Drug Code (US) Revision Year: 2022

Product description

ABSORICA

ABSORICA (isotretinoin) Capsules contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, each capsule contains the following inactive ingredients: propyl gallate, sorbitan monooleate, soybean oil and stearoyl polyoxylglycerides. The gelatin capsules contain the following dye systems:

10 mg – iron oxide (yellow) and titanium dioxide;
20 mg – iron oxide (red), and titanium dioxide;
25 mg – FD&C Blue #1, FD&C Yellow #5 [see Warnings and Precautions (5.14)], FD&C Yellow #6 and titanium dioxide;
30 mg – iron oxide (black, red and yellow) and titanium dioxide;
35 mg – FD&C Blue #2, iron oxide (black, red and yellow) and titanium dioxide;
40 mg – iron oxide (black, red and yellow) and titanium dioxide.

ABSORICA LD

ABSORICA LD (isotretinoin) Capsules contain 8 mg, 16 mg, 20 mg, 24 mg, 28 mg and 32 mg of micronized isotretinoin (a retinoid) in suspension filled in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, USP each capsule contains the following inactive ingredients: butylated hydroxy anisole, gelatin, hard gelatin capsule shell, polysorbate 80 and soybean oil. The gelatin capsules contain the following dye systems:

8 mg – D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and titanium dioxide
16 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide
20 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide
24 mg – D&C Yellow #10, FD&C Yellow #6 and titanium dioxide
28 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide
32 mg – ferrosoferric oxide, ferric oxide (red and yellow) and titanium dioxide

The imprinting ink of 8 mg, 16 mg, 24 mg and 32 mg capsules contain the following ingredients: potassium hydroxide, propylene glycol, shellac and titanium dioxide.

The imprinting ink of 20 mg and 28 mg capsules contain the following ingredients: ferrosoferric oxide, propylene glycol and shellac glaze.

Isotretinoin

Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. It is practically insoluble in water, soluble in chloroform and sparingly soluble in alcohol and in isopropyl alcohol. The structural formula is:

ABSORICA meets USP Dissolution Test 3.

For ABSORICA LD, FDA approved dissolution test differs from the USP.

Dosage Forms and Strengths
ABSORICA and ABSORICA LD have different dosage regimens [see Dosage and Administration (2.1)]. Although ABSORICA and ABSORICA LD have a 20 mg strength, these strengths have different bioavailability and are not substitutable. ABSORICA is available in 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg capsules. 10 mg: Dark yellow, opaque, capsule imprinted with black ink “G 240” on cap and “10” on the body 20 mg: Red, opaque, capsule imprinted with black ink “G 241” on cap and “20” on the body 25 mg: Green, opaque, capsule imprinted with white ink “G 342” on cap and “25” on the body 30 mg: Brown, opaque, capsule imprinted with white ink “G 242” on cap and “30” on the body 35 mg: Dark blue, opaque, capsule imprinted with white ink “G 343” on cap and “35” on the body 40 mg: Brown and red, capsule imprinted with white ink “G 325” on cap and “40” on the body ABSORICA LD is available in 8 mg, 16 mg, 20 mg, 24 mg, 28 mg and 32 mg opaque-printed, hard-gelatin capsules. 8 mg: A size 3, light green with a colorless band (the cap is printed in white with “RL29” and the body is printed in white with “RL29”). 16 mg: A size 2, dark blue with a colorless band (the cap is printed in white with “RL30” and the body is printed in white with “RL30”). 20 mg: A size 1, dark pink with a colorless band (the cap is printed in black with "RL33"and the body is printed in black with “RL33”). 24 mg: A size 1, yellow with a colorless band (the cap is printed in white with “RL31” and the body is printed in white with “RL31”). 28 mg: A size 0, light blue, with a colorless band (the cap is printed in black with “RL34” and the body is printed in black with “RL34”). 32 mg: A size 0, caramel with a colorless band (the cap is printed in white with “RL32” and the body is printed in white with “RL32”).

How Supplied
ABSORICA and ABSORICA LD have different dosage regimens. Although ABSORICA and ABSORICA LD have a 20 mg strength, these strengths have different bioavailability and are not substitutable [see Dosage and Administration (2.1)]. ABSORICA ABSORICA (isotretinoin) Capsules (opaque) are supplied as follows: 10 mg: Dark yellow, capsule imprinted with black ink “G 240” on cap and “10” on the body. Box of 30 capsules (3 × 10 Prescription Packs): NDC 10631-115-31. 20 mg: Red, capsule imprinted with black ink “G 241” on cap and “20” on the body. Box of 30 capsules (3 × 10 Prescription Packs): NDC 10631-116-31. 25 mg: Green, capsule imprinted with white ink “G 342” on cap and “25” on the body. Box of 30 capsules (3 × 10 Prescription Packs): NDC 10631-133-31. 30 mg: Brown, capsule imprinted with white ink “G 242” on cap and “30” on the body. Box of 30 capsules (3 × 10 Prescription Packs): NDC 10631-117-31. 35 mg: Dark blue, capsule imprinted with white ink “G 343” on cap and “35” on the body. Box of 30 capsules (3 × 10 Prescription Packs): NDC 10631-134-31. 40 mg: Brown and red, capsule imprinted with white ink “G 325” on cap and “40” on the body. Box of 30 capsules (3 × 10 Prescription Packs): NDC 10631-118-31. ABSORICA LD ABSORICA LD (isotretinoin) Capsules (opaque-printed, hard-gelatin) are supplied as follows: 8 mg: A size 3, light green, capsules banded with a colorless band. The cap is printed in white with “RL29” and the body is printed in white with “RL29”. Box of 30 capsules (3 × 10 Prescription Packs) NDC 10631-002-31. 16 mg: A size 2, dark blue, capsules banded with a colorless band. The cap is printed in white with “RL30” and the body is printed in white with “RL30”. Box of 30 capsules (3 × 10 Prescription Packs) NDC 10631-003-31. 20 mg: A size 1, dark pink, capsules banded with a colorless band. The cap is printed in black with "RL33"and the body is printed in black with “RL33”. Box of 30 capsules (3 × 10 Prescription Packs) NDC 10631-004-31. 24 mg: A size 1, yellow, capsules banded with a colorless band. The cap is printed in white with “RL31” and the body is printed in white with “RL31”. Box of 30 capsules (3 × 10 Prescription Packs) NDC 10631-005-31. 28 mg: A size 0, light blue, capsules banded with a colorless band. The cap is printed in black with “RL34” and the body is printed in black with “RL34”. Box of 30 capsules (3 × 10 Prescription Packs) NDC 10631-006-31. 32 mg: A size 0, caramel, capsules banded with a colorless band. The cap is printed in white with “RL32” and the body is printed in white with “RL32”. Box of 30 capsules (3 × 10 Prescription Packs): NDC 10631-007-31. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512

Drugs

Drug	Countries
ABSORICA	United States

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