pregabalin

Generic: pregabalin

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 100 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-689
Product ID 47335-689_52bb3d43-24c1-4789-8423-6c2d54850e75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091157
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2019-12-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335689
Hyphenated Format 47335-689

Supplemental Identifiers

RxCUI
483438 483440 483442 483444 483446 483448 483450 577127
UPC
0347335692884 0347335693881 0347335688887 0347335689884 0347335686883 0347335687880 0347335691887 0347335690880
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 ANDA091157 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (47335-689-08)
  • 1000 CAPSULE in 1 BOTTLE (47335-689-18)
  • 30 CAPSULE in 1 BOTTLE (47335-689-83)
  • 100 CAPSULE in 1 BOTTLE (47335-689-88)
source: ndc

Packages (4)

47335-689-08 100 CAPSULE in 1 BOTTLE (47335-689-08) 47335-689-18 1000 CAPSULE in 1 BOTTLE (47335-689-18) 47335-689-83 30 CAPSULE in 1 BOTTLE (47335-689-83) 47335-689-88 100 CAPSULE in 1 BOTTLE (47335-689-88)

Ingredients (1)

pregabalin (100 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": "52bb3d43-24c1-4789-8423-6c2d54850e75", "openfda": {"upc": ["0347335692884", "0347335693881", "0347335688887", "0347335689884", "0347335686883", "0347335687880", "0347335691887", "0347335690880"], "unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["ee7b9119-e88f-48ad-ae97-55e53374e62f"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (47335-689-08)", "package_ndc": "47335-689-08", "marketing_start_date": "20191204"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (47335-689-18)", "package_ndc": "47335-689-18", "marketing_start_date": "20191204"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (47335-689-83)", "package_ndc": "47335-689-83", "marketing_start_date": "20191204"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (47335-689-88)", "package_ndc": "47335-689-88", "marketing_start_date": "20191204"}], "brand_name": "Pregabalin", "product_id": "47335-689_52bb3d43-24c1-4789-8423-6c2d54850e75", "dosage_form": "CAPSULE", "product_ndc": "47335-689", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "100 mg/1"}], "application_number": "ANDA091157", "marketing_category": "ANDA", "marketing_start_date": "20191204", "listing_expiration_date": "20261231"}