isotretinoin

Generic: isotretinoin

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name isotretinoin
Generic Name isotretinoin
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

isotretinoin 25 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-022
Product ID 57664-022_0e924cf6-5375-28c4-e063-6294a90a4ac4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021951
Listing Expiration 2026-12-31
Marketing Start 2020-12-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57664022
Hyphenated Format 57664-022

Supplemental Identifiers

RxCUI
197843 197844 197845 403930 1547561 1547565
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 NDA021951 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 BOX (57664-022-97) / 10 CAPSULE in 1 BLISTER PACK (57664-022-98)
source: ndc

Packages (1)

57664-022-97 3 BLISTER PACK in 1 BOX (57664-022-97) / 10 CAPSULE in 1 BLISTER PACK (57664-022-98)

Ingredients (1)

isotretinoin (25 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": "0e924cf6-5375-28c4-e063-6294a90a4ac4", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "403930", "1547561", "1547565"], "spl_set_id": ["b44200ba-6672-4ea7-b151-7caec3f53c9c"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 BOX (57664-022-97)  / 10 CAPSULE in 1 BLISTER PACK (57664-022-98)", "package_ndc": "57664-022-97", "marketing_start_date": "20201229"}], "brand_name": "Isotretinoin", "product_id": "57664-022_0e924cf6-5375-28c4-e063-6294a90a4ac4", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "57664-022", "generic_name": "Isotretinoin", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isotretinoin", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "25 mg/1"}], "application_number": "NDA021951", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20201229", "listing_expiration_date": "20261231"}