NDC 10631-115

Absorica

Isotretinoin

Absorica 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: 10631-115_226dda6c-17ec-4e33-858a-86c0654d9946
• NDC: 10631-115
• Product Type: Human Prescription Drug
• Proprietary Name: Absorica
• Generic Name: Isotretinoin
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2012-06-08
• Marketing Category: NDA / NDA
• Application Number: NDA021951
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: ISOTRETINOIN
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Retinoid [EPC],Retinoids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 10631-115-31

3 BLISTER PACK in 1 BOX (10631-115-31) > 10 CAPSULE in 1 BLISTER PACK (10631-115-69)

• Marketing Start Date: 2012-06-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10631-115-69 [10631011569]

Absorica CAPSULE

• Marketing Category: NDA
• Application Number: NDA021951
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-06-08

NDC 10631-115-31 [10631011531]

Absorica CAPSULE

• Marketing Category: NDA
• Application Number: NDA021951
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-06-08

Drug Details

Active Ingredients

Ingredient	Strength
ISOTRETINOIN	10 mg/1

OpenFDA Data

• SPL SET ID: 3ef0cff8-19c1-4441-b780-fca6c7ee1615
• Manufacturer:
  • Sun Pharmaceutical Industries, Inc.
• UNII:
  • EH28UP18IF
• RxNorm Concept Unique ID - RxCUI:
  • 197843
  • 403930
  • 197845
  • 197844
  • 1299203
  • 1300014
  • 1300006
  • 1300016
  • 1547567
  • 1547565
  • 1547563
  • 1547561

Pharmacological Class

• Retinoid [EPC]
• Retinoids [CS]

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

NDC	Brand Name	Generic Name
10631-134	Absorica	Absorica
10631-116	Absorica	Absorica
10631-115	Absorica	Absorica
10631-118	Absorica	Absorica
10631-133	Absorica	Absorica
10631-117	Absorica	Absorica
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