saxagliptin and metformin hydrochloride

Generic: saxagliptin and metformin hydrochloride

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

Drug Facts

Product Profile

Brand Name saxagliptin and metformin hydrochloride
Generic Name saxagliptin and metformin hydrochloride
Labeler dr.reddys laboratories inc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1, saxagliptin 2.5 mg/1

Manufacturer
Dr.Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-618
Product ID 43598-618_833f258a-606f-1ca2-86fe-2f7cf1aab593
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207678
Listing Expiration 2026-12-31
Marketing Start 2023-08-09

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs] dipeptidyl peptidase 4 inhibitor [epc] dipeptidyl peptidase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598618
Hyphenated Format 43598-618

Supplemental Identifiers

RxCUI
1043563 1043570 1043578
UPC
0343598618609 0343598620305
UNII
9GB927LAJW 786Z46389E

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 saxagliptin and metformin hydrochloride (source: ndc)
Generic Name saxagliptin and metformin hydrochloride (source: ndc)
Application Number ANDA207678 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
  • 2.5 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-618-60)
source: ndc

Packages (1)

43598-618-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-618-60)

Ingredients (2)

metformin hydrochloride (1000 mg/1) saxagliptin (2.5 mg/1)

Linked Drug Pages (1)

Saxagliptin and Metformin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "833f258a-606f-1ca2-86fe-2f7cf1aab593", "openfda": {"upc": ["0343598618609", "0343598620305"], "unii": ["9GB927LAJW", "786Z46389E"], "rxcui": ["1043563", "1043570", "1043578"], "spl_set_id": ["65884427-4dde-63bb-a23f-36a7779c0a6b"], "manufacturer_name": ["Dr.Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-618-60)", "package_ndc": "43598-618-60", "marketing_start_date": "20230809"}], "brand_name": "Saxagliptin and Metformin Hydrochloride", "product_id": "43598-618_833f258a-606f-1ca2-86fe-2f7cf1aab593", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "43598-618", "generic_name": "Saxagliptin and Metformin Hydrochloride", "labeler_name": "Dr.Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Saxagliptin and Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}, {"name": "SAXAGLIPTIN", "strength": "2.5 mg/1"}], "application_number": "ANDA207678", "marketing_category": "ANDA", "marketing_start_date": "20230809", "listing_expiration_date": "20261231"}