pregabalin

Generic: pregabalin

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler amneal pharmaceuticals ny llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 200 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1315
Product ID 69238-1315_670cafeb-c249-4782-838c-9537d3ede28b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209743
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 692381315
Hyphenated Format 69238-1315

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
UPC
0369238131796 0369238131451 0369238131758 0369238131550 0369238131598 0369238131055 0369238131659 0369238131253 0369238131154
UNII
55JG375S6M

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 pregabalin (source: ndc)
Generic Name pregabalin (source: ndc)
Application Number ANDA209743 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (69238-1315-5)
  • 90 CAPSULE in 1 BOTTLE (69238-1315-9)
source: ndc

Packages (2)

69238-1315-5 500 CAPSULE in 1 BOTTLE (69238-1315-5) 69238-1315-9 90 CAPSULE in 1 BOTTLE (69238-1315-9)

Ingredients (1)

pregabalin (200 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": "670cafeb-c249-4782-838c-9537d3ede28b", "openfda": {"upc": ["0369238131796", "0369238131451", "0369238131758", "0369238131550", "0369238131598", "0369238131055", "0369238131659", "0369238131253", "0369238131154"], "unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["3d9d7123-5886-4b61-a7ea-471b213e77d9"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (69238-1315-5)", "package_ndc": "69238-1315-5", "marketing_start_date": "20190719"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (69238-1315-9)", "package_ndc": "69238-1315-9", "marketing_start_date": "20190719"}], "brand_name": "Pregabalin", "product_id": "69238-1315_670cafeb-c249-4782-838c-9537d3ede28b", "dosage_form": "CAPSULE", "product_ndc": "69238-1315", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "200 mg/1"}], "application_number": "ANDA209743", "marketing_category": "ANDA", "marketing_start_date": "20190719", "listing_expiration_date": "20261231"}