Home NDC 50090-5502 JANUMET
Product NDC 50090-5502
11-digit product format 500905502
Labeler code 50090
Product ID 50090-5502_e60a2c11-c521-495d-bc7c-10612ea7b2fa
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 SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
Active strength 50; 1000 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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.
Product history page 1 of 3 · 86 observed 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 2026-09-14 22:38:34 2026-08 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL AB RLD 2007-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL AB RLD, RS 2007-03-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL AB RLD 2007-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL AB RLD, RS 2007-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL AB RLD 2007-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL AB RLD, RS 2007-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL AB RLD 2007-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL AB RLD, RS 2007-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022044-001 JANUMET 500MG;EQ 50MG BASE TABLET / ORAL RLD 2007-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022044-002 JANUMET 1GM;EQ 50MG BASE TABLET / ORAL RLD, RS 2007-03-30 74a2ff9319b5…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 15 · 568 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022044-001 7326708 2026-11-24 U-802 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022044-001 7326708*PED 2027-05-24 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022044-001 8414921 2028-07-21 U-1036 Drug product 2013-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022044-001 8414921*PED 2029-01-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022044-002 7326708 2026-11-24 U-802 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022044-002 7326708*PED 2027-05-24 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022044-002 8414921 2028-07-21 U-1036 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022044-002 8414921*PED 2029-01-21 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022044-001 7326708 2026-11-24 U-802 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022044-001 7326708*PED 2027-05-24 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022044-001 8414921 2028-07-21 U-1036 Drug product 2013-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022044-001 8414921*PED 2029-01-21 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022044-002 7326708 2026-11-24 U-802 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022044-002 7326708*PED 2027-05-24 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022044-002 8414921 2028-07-21 U-1036 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022044-002 8414921*PED 2029-01-21 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022044-001 7326708 2026-11-24 U-802 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022044-001 7326708*PED 2027-05-24 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022044-001 8414921 2028-07-21 U-1036 Drug product 2013-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022044-001 8414921*PED 2029-01-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022044-002 7326708 2026-11-24 U-802 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022044-002 7326708*PED 2027-05-24 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022044-002 8414921 2028-07-21 U-1036 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022044-002 8414921*PED 2029-01-21 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022044-001 7326708 2026-11-24 U-802 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022044-001 7326708*PED 2027-05-24 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022044-001 8414921 2028-07-21 U-1036 Drug product 2013-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022044-001 8414921*PED 2029-01-21 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022044-002 7326708 2026-11-24 U-802 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022044-002 7326708*PED 2027-05-24 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022044-002 8414921 2028-07-21 U-1036 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022044-002 8414921*PED 2029-01-21 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022044-001 7326708 2026-11-24 U-802 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022044-001 7326708*PED 2027-05-24 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022044-001 8414921 2028-07-21 U-1036 Drug product 2013-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022044-001 8414921*PED 2029-01-21 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022044-002 7326708 2026-11-24 U-802 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022044-002 7326708*PED 2027-05-24 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022044-002 8414921 2028-07-21 U-1036 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022044-002 8414921*PED 2029-01-21 Pediatric extension 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 180 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base JANUMET
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SITAGLIPTIN PHOSPHATE 50 mg/1 METFORMIN HYDROCHLORIDE 1000 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
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