claravis

Generic: isotretinoin

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name claravis
Generic Name isotretinoin
Labeler teva pharmaceuticals usa, inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

isotretinoin 20 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-1055
Product ID 0555-1055_a69dde5d-5585-4313-be43-02d11fec4c9f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076135
Listing Expiration 2026-12-31
Marketing Start 2003-05-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05551055
Hyphenated Format 0555-1055

Supplemental Identifiers

RxCUI
197843 197844 197845 403930 404059 404062 404065 643488
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 claravis (source: ndc)
Generic Name isotretinoin (source: ndc)
Application Number ANDA076135 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (0555-1055-56) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1055-60)
  • 3 BLISTER PACK in 1 CARTON (0555-1055-86) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1055-60)
source: ndc

Packages (2)

0555-1055-56 10 BLISTER PACK in 1 CARTON (0555-1055-56) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1055-60) 0555-1055-86 3 BLISTER PACK in 1 CARTON (0555-1055-86) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1055-60)

Ingredients (1)

isotretinoin (20 mg/1)

Linked Drug Pages (1)

Claravis ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a69dde5d-5585-4313-be43-02d11fec4c9f", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["EH28UP18IF"], "rxcui": ["197843", "197844", "197845", "403930", "404059", "404062", "404065", "643488"], "spl_set_id": ["a31fd109-d0fd-4ab9-ba98-a3d64333c18d"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (0555-1055-56)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1055-60)", "package_ndc": "0555-1055-56", "marketing_start_date": "20030509"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0555-1055-86)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1055-60)", "package_ndc": "0555-1055-86", "marketing_start_date": "20030509"}], "brand_name": "Claravis", "product_id": "0555-1055_a69dde5d-5585-4313-be43-02d11fec4c9f", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0555-1055", "generic_name": "Isotretinoin", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Claravis", "active_ingredients": [{"name": "ISOTRETINOIN", "strength": "20 mg/1"}], "application_number": "ANDA076135", "marketing_category": "ANDA", "marketing_start_date": "20030509", "listing_expiration_date": "20261231"}