NDC 0555-1057

Claravis

Isotretinoin

Claravis is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Isotretinoin.

• Product ID: 0555-1057_10276cf5-9f65-4a32-8b0d-201fa5b2bc20
• NDC: 0555-1057
• Product Type: Human Prescription Drug
• Proprietary Name: Claravis
• Generic Name: Isotretinoin
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2003-05-09
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076135
• Labeler Name: Teva Pharmaceuticals USA, Inc.
• Substance Name: ISOTRETINOIN
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Retinoid [EPC],Retinoids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0555-1057-56

10 BLISTER PACK in 1 CARTON (0555-1057-56) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1057-60)

• Marketing Start Date: 2003-05-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0555-1057-86 [00555105786]

Claravis CAPSULE, LIQUID FILLED

• Marketing Category: ANDA
• Application Number: ANDA076135
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-05-09

NDC 0555-1057-60 [00555105760]

Claravis CAPSULE, LIQUID FILLED

• Marketing Category: ANDA
• Application Number: ANDA076135
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-05

NDC 0555-1057-56 [00555105756]

Claravis CAPSULE, LIQUID FILLED

• Marketing Category: ANDA
• Application Number: ANDA076135
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-05-09

Drug Details

Active Ingredients

Ingredient	Strength
ISOTRETINOIN	40 mg/1

OpenFDA Data

• SPL SET ID: a31fd109-d0fd-4ab9-ba98-a3d64333c18d
• Manufacturer:
  • Teva Pharmaceuticals USA, Inc.
• UNII:
  • EH28UP18IF
• RxNorm Concept Unique ID - RxCUI:
  • 404059
  • 197843
  • 403930
  • 197845
  • 197844
  • 404065
  • 404062
  • 643488

Pharmacological Class

• Retinoid [EPC]
• Retinoids [CS]
• Retinoid [EPC]
• Retinoids [CS]

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

NDC	Brand Name	Generic Name
0555-1054	Claravis	Isotretinoin
0555-1055	Claravis	Isotretinoin
0555-1056	Claravis	Isotretinoin
0555-1057	Claravis	Isotretinoin
0378-6611	Amnesteem	isotretinoin
0378-6612	Amnesteem	isotretinoin
0378-6614	Amnesteem	isotretinoin
0245-0570	Isotretinoin	Isotretinoin
0245-0571	Isotretinoin	Isotretinoin
0245-0573	Isotretinoin	Isotretinoin
0245-0575	Isotretinoin	Isotretinoin