pregabalin

Generic: pregabalin

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

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler asclemed usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 25 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-095
Product ID 76420-095_ead3b1c9-5c7d-457b-e053-2995a90a71ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208677
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2019-07-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420095
Hyphenated Format 76420-095

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
UNII
55JG375S6M

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 pregabalin (source: ndc)
Generic Name pregabalin (source: ndc)
Application Number ANDA208677 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (76420-095-30)
  • 60 CAPSULE in 1 BOTTLE (76420-095-60)
  • 90 CAPSULE in 1 BOTTLE (76420-095-90)
source: ndc

Packages (3)

76420-095-30 30 CAPSULE in 1 BOTTLE (76420-095-30) 76420-095-60 60 CAPSULE in 1 BOTTLE (76420-095-60) 76420-095-90 90 CAPSULE in 1 BOTTLE (76420-095-90)

Ingredients (1)

pregabalin (25 mg/1)

Linked Drug Pages (1)

Pregabalin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ead3b1c9-5c7d-457b-e053-2995a90a71ef", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["3d2464fb-b3ac-496e-b8a5-c2e8a902ce29"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-095-30)", "package_ndc": "76420-095-30", "marketing_start_date": "20200617"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-095-60)", "package_ndc": "76420-095-60", "marketing_start_date": "20200617"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-095-90)", "package_ndc": "76420-095-90", "marketing_start_date": "20200617"}], "brand_name": "Pregabalin", "product_id": "76420-095_ead3b1c9-5c7d-457b-e053-2995a90a71ef", "dosage_form": "CAPSULE", "product_ndc": "76420-095", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "25 mg/1"}], "application_number": "ANDA208677", "marketing_category": "ANDA", "marketing_start_date": "20190719", "listing_expiration_date": "20261231"}