NDC 10631-002

Absorica LD

Isotretinoin

Absorica LD is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Isotretinoin.

• Product ID: 10631-002_2624e8da-e473-4136-b6c6-a59b6cc14d01
• NDC: 10631-002
• Product Type: Human Prescription Drug
• Proprietary Name: Absorica LD
• Generic Name: Isotretinoin
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2019-11-20
• Marketing Category: NDA / NDA
• Application Number: NDA211913
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: ISOTRETINOIN
• Active Ingredient Strength: 8 mg/1
• Pharm Classes: Retinoid [EPC],Retinoids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 10631-002-31

3 BLISTER PACK in 1 BOX (10631-002-31) > 10 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 2019-11-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10631-002-31 [10631000231]

Absorica LD CAPSULE

• Marketing Category: NDA
• Application Number: NDA211913
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-11-20

Drug Details

Active Ingredients

Ingredient	Strength
ISOTRETINOIN	8 mg/1

Pharmacological Class

• Retinoid [EPC]
• Retinoids [CS]

NDC Crossover Matching brand name "Absorica LD" or generic name "Isotretinoin"

NDC	Brand Name	Generic Name
10631-005	Absorica LD	Absorica LD
10631-006	Absorica LD	Absorica LD
10631-002	Absorica LD	Absorica LD
10631-003	Absorica LD	Absorica LD
10631-007	Absorica LD	Absorica LD
10631-004	Absorica LD	Absorica LD
0378-6611	Amnesteem	isotretinoin
0378-6612	Amnesteem	isotretinoin
0378-6614	Amnesteem	isotretinoin
0555-1054	Claravis	Isotretinoin
0555-1055	Claravis	Isotretinoin
0555-1056	Claravis	Isotretinoin
0555-1057	Claravis	Isotretinoin
0245-0570	Isotretinoin	Isotretinoin
0245-0571	Isotretinoin	Isotretinoin
0245-0573	Isotretinoin	Isotretinoin
0245-0575	Isotretinoin	Isotretinoin