absorica ld

Generic: isotretinoin

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

Drug Facts

Product Profile

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

isotretinoin 16 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 10631-003
Product ID 10631-003_fba81535-0761-42a7-b422-338f8bd2cfc6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211913
Listing Expiration 2026-12-31
Marketing Start 2019-11-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10631003
Hyphenated Format 10631-003

Supplemental Identifiers

RxCUI
197843 197844 197845 403930 1299203 1300006 1300014 1300016 1547561 1547563 1547565 1547567 2262711 2262713 2262714 2262715 2262717 2262719 2262721 2262723 2262725 2262727 2262729 2262731
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 absorica ld (source: ndc)
Generic Name isotretinoin (source: ndc)
Application Number NDA211913 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 16 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 BOX (10631-003-31) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

10631-003-31 3 BLISTER PACK in 1 BOX (10631-003-31) / 10 CAPSULE in 1 BLISTER PACK

Ingredients (1)

isotretinoin (16 mg/1)

Linked Drug Pages (1)

Absorica LD, Absorica ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fba81535-0761-42a7-b422-338f8bd2cfc6", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "403930", "1299203", "1300006", "1300014", "1300016", "1547561", "1547563", "1547565", "1547567", "2262711", "2262713", "2262714", "2262715", "2262717", "2262719", "2262721", "2262723", "2262725", "2262727", "2262729", "2262731"], "spl_set_id": ["3ef0cff8-19c1-4441-b780-fca6c7ee1615"], "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 (10631-003-31)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "10631-003-31", "marketing_start_date": "20191120"}], "brand_name": "Absorica LD", "product_id": "10631-003_fba81535-0761-42a7-b422-338f8bd2cfc6", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "10631-003", "generic_name": "isotretinoin", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Absorica LD", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "16 mg/1"}], "application_number": "NDA211913", "marketing_category": "NDA", "marketing_start_date": "20191120", "listing_expiration_date": "20261231"}