amnesteem

Generic: isotretinoin

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amnesteem
Generic Name isotretinoin
Labeler mylan pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

isotretinoin 40 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6614
Product ID 0378-6614_8105505f-9df6-4bc4-b201-7281a2d3af00
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075945
Listing Expiration 2026-12-31
Marketing Start 2002-11-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03786614
Hyphenated Format 0378-6614

Supplemental Identifiers

RxCUI
197843 197844 197845 403930 404058 404061 404064 2711694
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 amnesteem (source: ndc)
Generic Name isotretinoin (source: ndc)
Application Number ANDA075945 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (0378-6614-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6614-85)
source: ndc

Packages (1)

0378-6614-93 3 BLISTER PACK in 1 CARTON (0378-6614-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6614-85)

Ingredients (1)

isotretinoin (40 mg/1)

Linked Drug Pages (1)

Amnesteem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8105505f-9df6-4bc4-b201-7281a2d3af00", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "403930", "404058", "404061", "404064", "2711694"], "spl_set_id": ["b2cb63c9-f825-4991-9a2c-6260f1bbcc2c"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0378-6614-93)  / 10 CAPSULE in 1 BLISTER PACK (0378-6614-85)", "package_ndc": "0378-6614-93", "marketing_start_date": "20021111"}], "brand_name": "Amnesteem", "product_id": "0378-6614_8105505f-9df6-4bc4-b201-7281a2d3af00", "dosage_form": "CAPSULE", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0378-6614", "generic_name": "isotretinoin", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amnesteem", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "40 mg/1"}], "application_number": "ANDA075945", "marketing_category": "ANDA", "marketing_start_date": "20021111", "listing_expiration_date": "20261231"}