Home NDC 50090-5502 JANUMET
Product NDC 50090-5502
11-digit product format 500905502
Labeler code 50090
Product ID 50090-5502_7511c56d-21ea-4bad-89b9-62329c2e3d75
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SITAGLIPTIN and METFORMIN HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application NDA022044
Marketing category NDA
Marketing start 2007-03-30
Substance METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Active strength 1000; 50 mg/1; mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022044-001 JANUMET METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 500MG;EQ 50MG BASE TABLET / ORAL AB RLD 2007-03-30 N022044-002 JANUMET METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 1GM;EQ 50MG BASE TABLET / ORAL AB RLD, RS 2007-03-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022044-001 7326708 2026-11-24 U-802 Drug substance, Drug product N022044-001 7326708*PED 2027-05-24 Pediatric extension N022044-001 8414921 2028-07-21 U-1036 Drug product 2013-04-09 N022044-001 8414921*PED 2029-01-21 Pediatric extension N022044-002 7326708 2026-11-24 U-802 Drug substance, Drug product N022044-002 7326708*PED 2027-05-24 Pediatric extension N022044-002 8414921 2028-07-21 U-1036 Drug product N022044-002 8414921*PED 2029-01-21 Pediatric extension
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL AB RLD 2007-03-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL AB RLD, RS 2007-03-30 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N022044-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 N022044-002 AB 1 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N022044-001 7326708 2026-11-24 U-802 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022044-001 7326708*PED 2027-05-24 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022044-001 8414921 2028-07-21 U-1036 Drug product 2013-04-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N022044-001 8414921*PED 2029-01-21 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022044-002 7326708 2026-11-24 U-802 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022044-002 7326708*PED 2027-05-24 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022044-002 8414921 2028-07-21 U-1036 Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022044-002 8414921*PED 2029-01-21 Pediatric extension a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base JANUMET
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SITAGLIPTIN PHOSPHATE 1000 mg/1 METFORMIN HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TS63EW8X6F Internal UNII lookup 786Z46389E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861771 Internal RxNorm lookup 2709488 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5502-0 JANUMET 60 in 1 BOTTLE TABLET, FILM COATED 60 9 50090-5502-1 JANUMET 180 in 1 BOTTLE TABLET, FILM COATED 180 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5502 JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 9 Current NDC, 2 package rows 20230722_c603b844-2019-4ef4-8385-7bc3f96a2565.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50090-5502-0 50090550200 60 TABLET, FILM COATED in 1 BOTTLE (50090-5502-0) 2021-03-31 No No Current 50090-5502-1 50090550201 180 TABLET, FILM COATED in 1 BOTTLE (50090-5502-1) 2023-07-19 No No Current