NDC 55111-113

ZENATANE

Isotretinoin

ZENATANE is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddy's Laboratories Limited. The primary component is Isotretinoin.

• Product ID: 55111-113_1f5178c1-0f6f-824d-d0ee-1b973377ccc6
• NDC: 55111-113
• Product Type: Human Prescription Drug
• Proprietary Name: ZENATANE
• Generic Name: Isotretinoin
• Dosage Form: Capsule, Gelatin Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-03-09
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202099
• Labeler Name: Dr. Reddy's Laboratories Limited
• Substance Name: ISOTRETINOIN
• Active Ingredient Strength: 30 mg/1
• Pharm Classes: Retinoid [EPC],Retinoids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55111-113-78

10 BLISTER PACK in 1 CARTON (55111-113-78) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)

• Marketing Start Date: 2015-03-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55111-113-78 [55111011378]

ZENATANE CAPSULE, GELATIN COATED

• Marketing Category: ANDA
• Application Number: ANDA202099
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-03-09

NDC 55111-113-79 [55111011379]

ZENATANE CAPSULE, GELATIN COATED

• Marketing Category: ANDA
• Application Number: ANDA202099
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-03-09

NDC 55111-113-81 [55111011381]

ZENATANE CAPSULE, GELATIN COATED

• Marketing Category: ANDA
• Application Number: ANDA202099
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-03-09

Drug Details

Active Ingredients

Ingredient	Strength
ISOTRETINOIN	30 mg/1

OpenFDA Data

• SPL SET ID: 27b3cf26-f22e-5b70-1c24-009933b7c6ee
• Manufacturer:
  • Dr. Reddy's Laboratories Limited
• UNII:
  • EH28UP18IF
• RxNorm Concept Unique ID - RxCUI:
  • 197843
  • 403930
  • 197845
  • 197844
  • 1373337
  • 1373335
  • 1373333
  • 1605088

Pharmacological Class

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

Medicade Reported Pricing

55111011381 ZENATANE 30 MG CAPSULE

Pricing Unit: EA | Drug Type:

55111011379 ZENATANE 30 MG CAPSULE

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
55111-135	ZENATANE	ZENATANE
55111-136	ZENATANE	ZENATANE
55111-137	ZENATANE	ZENATANE
55111-113	ZENATANE	ZENATANE
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