isotretinoin

Generic: isotretinoin

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isotretinoin
Generic Name isotretinoin
Labeler upsher-smith laboratories, llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

isotretinoin 20 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-8302
Product ID 0832-8302_4abc427d-939a-2bc9-e063-6294a90ae582
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076485
Listing Expiration 2027-12-31
Marketing Start 2012-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08328302
Hyphenated Format 0832-8302

Supplemental Identifiers

RxCUI
197843 197844 197845 403930
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 isotretinoin (source: ndc)
Generic Name isotretinoin (source: ndc)
Application Number ANDA076485 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 BOX (0832-8302-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8302-89)
source: ndc

Packages (1)

0832-8302-30 3 BLISTER PACK in 1 BOX (0832-8302-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8302-89)

Ingredients (1)

isotretinoin (20 mg/1)

Linked Drug Pages (1)

Isotretinoin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4abc427d-939a-2bc9-e063-6294a90ae582", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "403930"], "spl_set_id": ["c369e1c3-90c5-4768-9741-56c62253a2c4"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 BOX (0832-8302-30)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8302-89)", "package_ndc": "0832-8302-30", "marketing_start_date": "20230606"}], "brand_name": "Isotretinoin", "product_id": "0832-8302_4abc427d-939a-2bc9-e063-6294a90ae582", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0832-8302", "generic_name": "Isotretinoin", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isotretinoin", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "20 mg/1"}], "application_number": "ANDA076485", "marketing_category": "ANDA", "marketing_start_date": "20120501", "listing_expiration_date": "20271231"}