pregabalin

Generic: pregabalin

Labeler: dr.reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler dr.reddys laboratories inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 225 mg/1

Manufacturer
Dr.Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-297
Product ID 43598-297_4a1e5038-d049-606f-c087-48bc353a8a69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209664
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2019-07-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598297
Hyphenated Format 43598-297

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 ANDA209664 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 225 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (43598-297-05)
  • 5 BLISTER PACK in 1 CARTON (43598-297-66) / 10 CAPSULE in 1 BLISTER PACK (43598-297-79)
  • 10 BLISTER PACK in 1 CARTON (43598-297-78) / 10 CAPSULE in 1 BLISTER PACK (43598-297-79)
  • 90 CAPSULE in 1 BOTTLE (43598-297-90)
source: ndc

Packages (4)

43598-297-05 500 CAPSULE in 1 BOTTLE (43598-297-05) 43598-297-66 5 BLISTER PACK in 1 CARTON (43598-297-66) / 10 CAPSULE in 1 BLISTER PACK (43598-297-79) 43598-297-78 10 BLISTER PACK in 1 CARTON (43598-297-78) / 10 CAPSULE in 1 BLISTER PACK (43598-297-79) 43598-297-90 90 CAPSULE in 1 BOTTLE (43598-297-90)

Ingredients (1)

pregabalin (225 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": "4a1e5038-d049-606f-c087-48bc353a8a69", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127"], "spl_set_id": ["ceed457b-8f43-4021-fd70-071c96e09470"], "manufacturer_name": ["Dr.Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (43598-297-05)", "package_ndc": "43598-297-05", "marketing_start_date": "20190719"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (43598-297-66)  / 10 CAPSULE in 1 BLISTER PACK (43598-297-79)", "package_ndc": "43598-297-66", "marketing_start_date": "20190719"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (43598-297-78)  / 10 CAPSULE in 1 BLISTER PACK (43598-297-79)", "package_ndc": "43598-297-78", "marketing_start_date": "20190719"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (43598-297-90)", "package_ndc": "43598-297-90", "marketing_start_date": "20190719"}], "brand_name": "pregabalin", "product_id": "43598-297_4a1e5038-d049-606f-c087-48bc353a8a69", "dosage_form": "CAPSULE", "product_ndc": "43598-297", "dea_schedule": "CV", "generic_name": "pregabalin", "labeler_name": "Dr.Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "225 mg/1"}], "application_number": "ANDA209664", "marketing_category": "ANDA", "marketing_start_date": "20190719", "listing_expiration_date": "20261231"}