zenatane

Generic: isotretinoin

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zenatane
Generic Name isotretinoin
Labeler dr. reddy's laboratories limited
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

isotretinoin 30 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-113
Product ID 55111-113_d7d883f9-7d20-2c50-8023-e661b46dcd5b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202099
Listing Expiration 2026-12-31
Marketing Start 2015-03-09

Pharmacologic Class

Established (EPC)
retinoid [epc]
Chemical Structure
retinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111113
Hyphenated Format 55111-113

Supplemental Identifiers

RxCUI
197843 197844 197845 403930 1373333 1373335 1373337 1605088
UNII
EH28UP18IF
NUI
N0000175607 M0018962

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zenatane (source: ndc)
Generic Name isotretinoin (source: ndc)
Application Number ANDA202099 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (55111-113-78) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)
  • 3 BLISTER PACK in 1 CARTON (55111-113-81) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)
source: ndc

Packages (2)

55111-113-78 10 BLISTER PACK in 1 CARTON (55111-113-78) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79) 55111-113-81 3 BLISTER PACK in 1 CARTON (55111-113-81) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)

Ingredients (1)

isotretinoin (30 mg/1)

Linked Drug Pages (1)

ZENATANE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d7d883f9-7d20-2c50-8023-e661b46dcd5b", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "403930", "1373333", "1373335", "1373337", "1605088"], "spl_set_id": ["27b3cf26-f22e-5b70-1c24-009933b7c6ee"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-113-78)  / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)", "package_ndc": "55111-113-78", "marketing_start_date": "20150309"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (55111-113-81)  / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)", "package_ndc": "55111-113-81", "marketing_start_date": "20150309"}], "brand_name": "ZENATANE", "product_id": "55111-113_d7d883f9-7d20-2c50-8023-e661b46dcd5b", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "55111-113", "generic_name": "ISOTRETINOIN", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZENATANE", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "30 mg/1"}], "application_number": "ANDA202099", "marketing_category": "ANDA", "marketing_start_date": "20150309", "listing_expiration_date": "20261231"}