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 30 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0245-0573
Product ID 0245-0573_4ab8d5b7-3bd6-255a-e063-6294a90ae2cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212333
Listing Expiration 2027-12-31
Marketing Start 2021-09-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02450573
Hyphenated Format 0245-0573

Supplemental Identifiers

RxCUI
197843 197844 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 ANDA212333 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 BOX (0245-0573-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0245-0573-89)
source: ndc

Packages (1)

0245-0573-01 3 BLISTER PACK in 1 BOX (0245-0573-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0245-0573-89)

Ingredients (1)

isotretinoin (30 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": "4ab8d5b7-3bd6-255a-e063-6294a90ae2cb", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "403930"], "spl_set_id": ["08529687-26b2-41e5-b6fb-35b4c0d891fe"], "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 (0245-0573-01)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0245-0573-89)", "package_ndc": "0245-0573-01", "marketing_start_date": "20210921"}], "brand_name": "Isotretinoin", "product_id": "0245-0573_4ab8d5b7-3bd6-255a-e063-6294a90ae2cb", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0245-0573", "generic_name": "Isotretinoin", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isotretinoin", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "30 mg/1"}], "application_number": "ANDA212333", "marketing_category": "ANDA", "marketing_start_date": "20210921", "listing_expiration_date": "20271231"}