pregabalin

Generic: pregabalin

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler ascend laboratories, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 25 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-462
Product ID 67877-462_bf3e2485-edec-4163-b3ff-0e671f12df15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207799
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2019-10-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877462
Hyphenated Format 67877-462

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
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 ANDA207799 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (67877-462-05)
  • 30 CAPSULE in 1 BOTTLE (67877-462-30)
  • 1 BLISTER PACK in 1 CARTON (67877-462-33) / 10 CAPSULE in 1 BLISTER PACK
  • 10 BLISTER PACK in 1 CARTON (67877-462-38) / 10 CAPSULE in 1 BLISTER PACK
  • 90 CAPSULE in 1 BOTTLE (67877-462-90)
source: ndc

Packages (5)

67877-462-05 500 CAPSULE in 1 BOTTLE (67877-462-05) 67877-462-30 30 CAPSULE in 1 BOTTLE (67877-462-30) 67877-462-33 1 BLISTER PACK in 1 CARTON (67877-462-33) / 10 CAPSULE in 1 BLISTER PACK 67877-462-38 10 BLISTER PACK in 1 CARTON (67877-462-38) / 10 CAPSULE in 1 BLISTER PACK 67877-462-90 90 CAPSULE in 1 BOTTLE (67877-462-90)

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": "bf3e2485-edec-4163-b3ff-0e671f12df15", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["e48db3c2-7351-41f2-a451-5a8341c4125c"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (67877-462-05)", "package_ndc": "67877-462-05", "marketing_start_date": "20191002"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (67877-462-30)", "package_ndc": "67877-462-30", "marketing_start_date": "20191002"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (67877-462-33)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "67877-462-33", "marketing_start_date": "20191002"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-462-38)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "67877-462-38", "marketing_start_date": "20191002"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (67877-462-90)", "package_ndc": "67877-462-90", "marketing_start_date": "20191002"}], "brand_name": "Pregabalin", "product_id": "67877-462_bf3e2485-edec-4163-b3ff-0e671f12df15", "dosage_form": "CAPSULE", "product_ndc": "67877-462", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "25 mg/1"}], "application_number": "ANDA207799", "marketing_category": "ANDA", "marketing_start_date": "20191002", "listing_expiration_date": "20261231"}