pregabalin

Generic: pregabalin

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

Drug Facts

Product Profile

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

pregabalin 300 mg/1

Manufacturer
Creekwood Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 82619-129
Product ID 82619-129_40b92ce3-6161-36b7-e063-6394a90af51e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213423
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2024-09-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82619129
Hyphenated Format 82619-129

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
UPC
0382619124026 0382619129021 0382619128017 0382619127010 0382619129014 0382619125023 0382619127027 0382619126013 0382619122022 0382619126020 0382619125016 0382619123012 0382619128024 0382619123029 0382619122015 0382619124019
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 ANDA213423 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (82619-129-01)
  • 500 CAPSULE in 1 BOTTLE (82619-129-02)
source: ndc

Packages (2)

82619-129-01 90 CAPSULE in 1 BOTTLE (82619-129-01) 82619-129-02 500 CAPSULE in 1 BOTTLE (82619-129-02)

Ingredients (1)

pregabalin (300 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": "40b92ce3-6161-36b7-e063-6394a90af51e", "openfda": {"upc": ["0382619124026", "0382619129021", "0382619128017", "0382619127010", "0382619129014", "0382619125023", "0382619127027", "0382619126013", "0382619122022", "0382619126020", "0382619125016", "0382619123012", "0382619128024", "0382619123029", "0382619122015", "0382619124019"], "unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["bfe4108e-b2d2-4059-be16-21d3276c3ae4"], "manufacturer_name": ["Creekwood Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (82619-129-01)", "package_ndc": "82619-129-01", "marketing_start_date": "20240920"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (82619-129-02)", "package_ndc": "82619-129-02", "marketing_start_date": "20240920"}], "brand_name": "PREGABALIN", "product_id": "82619-129_40b92ce3-6161-36b7-e063-6394a90af51e", "dosage_form": "CAPSULE", "product_ndc": "82619-129", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "Creekwood Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREGABALIN", "active_ingredients": [{"name": "PREGABALIN", "strength": "300 mg/1"}], "application_number": "ANDA213423", "marketing_category": "ANDA", "marketing_start_date": "20240920", "listing_expiration_date": "20261231"}