pregabalin

Generic: pregabalin

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler alembic pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 25 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-119
Product ID 46708-119_b746d2ae-57e4-4a36-9524-35c4aa6b4ef2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203459
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 46708119
Hyphenated Format 46708-119

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
UPC
0346708126308 0346708122300 0346708125301
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 ANDA203459 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 CARTON (46708-119-10)
  • 30 CAPSULE in 1 BOTTLE (46708-119-30)
  • 90 CAPSULE in 1 BOTTLE (46708-119-90)
  • 1000 CAPSULE in 1 BOTTLE (46708-119-91)
source: ndc

Packages (4)

46708-119-10 100 CAPSULE in 1 CARTON (46708-119-10) 46708-119-30 30 CAPSULE in 1 BOTTLE (46708-119-30) 46708-119-90 90 CAPSULE in 1 BOTTLE (46708-119-90) 46708-119-91 1000 CAPSULE in 1 BOTTLE (46708-119-91)

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": "b746d2ae-57e4-4a36-9524-35c4aa6b4ef2", "openfda": {"upc": ["0346708126308", "0346708122300", "0346708125301"], "unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["78a36538-701d-4dd9-a7fc-87d505784c83"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 CARTON (46708-119-10)", "package_ndc": "46708-119-10", "marketing_start_date": "20190719"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (46708-119-30)", "package_ndc": "46708-119-30", "marketing_start_date": "20190719"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (46708-119-90)", "package_ndc": "46708-119-90", "marketing_start_date": "20190719"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (46708-119-91)", "package_ndc": "46708-119-91", "marketing_start_date": "20190719"}], "brand_name": "Pregabalin", "product_id": "46708-119_b746d2ae-57e4-4a36-9524-35c4aa6b4ef2", "dosage_form": "CAPSULE", "product_ndc": "46708-119", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "25 mg/1"}], "application_number": "ANDA203459", "marketing_category": "ANDA", "marketing_start_date": "20190719", "listing_expiration_date": "20261231"}