pregabalin

Generic: pregabalin

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pregabalin 50 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-019
Product ID 72189-019_2c4e85d7-3b08-6b90-e063-6294a90a0ea8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208677
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2019-07-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189019
Hyphenated Format 72189-019

Supplemental Identifiers

RxCUI
483448
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
  • 50 mg/1
source: ndc
Packaging
  • 180 CAPSULE in 1 BOTTLE (72189-019-82)
  • 90 CAPSULE in 1 BOTTLE (72189-019-90)
source: ndc

Packages (2)

72189-019-82 180 CAPSULE in 1 BOTTLE (72189-019-82) 72189-019-90 90 CAPSULE in 1 BOTTLE (72189-019-90)

Ingredients (1)

pregabalin (50 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": "2c4e85d7-3b08-6b90-e063-6294a90a0ea8", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483448"], "spl_set_id": ["8efb9652-86b9-4cb5-e053-2995a90adac0"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "180 CAPSULE in 1 BOTTLE (72189-019-82)", "package_ndc": "72189-019-82", "marketing_start_date": "20190731"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (72189-019-90)", "package_ndc": "72189-019-90", "marketing_start_date": "20190731"}], "brand_name": "PREGABALIN", "product_id": "72189-019_2c4e85d7-3b08-6b90-e063-6294a90a0ea8", "dosage_form": "CAPSULE", "product_ndc": "72189-019", "dea_schedule": "CV", "generic_name": "PREGABALIN", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREGABALIN", "active_ingredients": [{"name": "PREGABALIN", "strength": "50 mg/1"}], "application_number": "ANDA208677", "marketing_category": "ANDA", "marketing_start_date": "20190731", "listing_expiration_date": "20261231"}