tretinoin

Generic: tretinoin

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tretinoin
Generic Name tretinoin
Labeler glenmark pharmaceuticals inc., usa
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tretinoin 10 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-792
Product ID 68462-792_5761f729-3e1f-4fe7-9d5f-cfb652bf1625
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208279
Listing Expiration 2027-12-31
Marketing Start 2016-12-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462792
Hyphenated Format 68462-792

Supplemental Identifiers

RxCUI
199159
UPC
0368462792018
UNII
5688UTC01R
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 tretinoin (source: ndc)
Generic Name tretinoin (source: ndc)
Application Number ANDA208279 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68462-792-01)
source: ndc

Packages (1)

68462-792-01 100 CAPSULE in 1 BOTTLE (68462-792-01)

Ingredients (1)

tretinoin (10 mg/1)

Linked Drug Pages (1)

Tretinoin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5761f729-3e1f-4fe7-9d5f-cfb652bf1625", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0368462792018"], "unii": ["5688UTC01R"], "rxcui": ["199159"], "spl_set_id": ["264138c1-9e5f-45ef-be87-79ca97c989d9"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68462-792-01)", "package_ndc": "68462-792-01", "marketing_start_date": "20161223"}], "brand_name": "Tretinoin", "product_id": "68462-792_5761f729-3e1f-4fe7-9d5f-cfb652bf1625", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "68462-792", "generic_name": "Tretinoin", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tretinoin", "active_ingredients": [{"name": "TRETINOIN", "strength": "10 mg/1"}], "application_number": "ANDA208279", "marketing_category": "ANDA", "marketing_start_date": "20161223", "listing_expiration_date": "20271231"}