pregabalin

Generic: pregabalin

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pregabalin 200 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7003
Product ID 0904-7003_ce6f3554-3f28-4d2e-8f32-e0893f1f43a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210432
DEA Schedule cv
Listing Expiration 2027-12-31
Marketing Start 2019-07-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047003
Hyphenated Format 0904-7003

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 ANDA210432 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-7003-04) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7003-04 30 BLISTER PACK in 1 CARTON (0904-7003-04) / 1 CAPSULE in 1 BLISTER PACK

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": "ce6f3554-3f28-4d2e-8f32-e0893f1f43a5", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["2420e2d7-c01a-4590-88c5-6fe5361747e9"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-7003-04)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7003-04", "marketing_start_date": "20190719"}], "brand_name": "PREGABALIN", "product_id": "0904-7003_ce6f3554-3f28-4d2e-8f32-e0893f1f43a5", "dosage_form": "CAPSULE", "product_ndc": "0904-7003", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREGABALIN", "active_ingredients": [{"name": "PREGABALIN", "strength": "200 mg/1"}], "application_number": "ANDA210432", "marketing_category": "ANDA", "marketing_start_date": "20190719", "listing_expiration_date": "20271231"}