Home NDC 0006-0577 JANUMET
Product NDC 0006-0577
11-digit product format 000060577
Labeler code 0006
Product ID 0006-0577_601dfad8-02f7-4696-9fe2-548610338dc9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SITAGLIPTIN and METFORMIN HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Merck Sharp & Dohme LLC
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 2026-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861771 Internal RxNorm lookup 861821 Internal RxNorm lookup 2709488 Internal RxNorm lookup 2709491 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 0006-0577-01 JANUMET 10 in 1 BLISTER PACK TABLET, FILM COATED 10 60 0006-0577-02 JANUMET 14 in 1 BOTTLE TABLET, FILM COATED 14 60 0006-0577-03 JANUMET 2 in 1 CARTON TABLET, FILM COATED 2 60 0006-0577-52 JANUMET 5 in 1 CARTON TABLET, FILM COATED 5 60 0006-0577-56 JANUMET 4 in 1 CARTON TABLET, FILM COATED 4 60 0006-0577-56 JANUMET 2 in 1 POUCH TABLET, FILM COATED 2 60 0006-0577-61 JANUMET 60 in 1 BOTTLE TABLET, FILM COATED 60 60 0006-0577-62 JANUMET 180 in 1 BOTTLE TABLET, FILM COATED 180 60 0006-0577-82 JANUMET 1000 in 1 BOTTLE TABLET, FILM COATED 1000 60
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 33 SITAGLIPTIN PHOSPHATE ACTIVE INGREDIENT TS63EW8X6F JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 33 METFORMIN ACTIVE MOIETY 9100L32L2N JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 33 SITAGLIPTIN ACTIVE MOIETY QFP0P1DV7Z JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 33 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 33 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 33 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 33 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 33 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 33 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 33 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 33 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 33 TALC INACTIVE INGREDIENT 7SEV7J4R1U JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 33 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] 33
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-0577 JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME LLC] 60 Current NDC, Legacy NDC, 9 package rows 20250331_d19c7ed0-ad5c-426e-b2df-722508f97d67.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0006-0577-01 00006057701 10 in 1 BLISTER PACK Historical 0006-0577-02 00006057702 14 in 1 BOTTLE Historical 0006-0577-03 00006057703 2 BOTTLE in 1 CARTON (0006-0577-03) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-0577-02) 2 bottle 2007-03-30 0000-00-00 Yes No Current 0006-0577-52 00006057752 5 in 1 CARTON Historical 0006-0577-56 00006057756 4 POUCH in 1 CARTON (0006-0577-56) / 2 BLISTER PACK in 1 POUCH / 7 TABLET, FILM COATED in 1 BLISTER PACK 4 pouch 2007-03-30 0000-00-00 Yes No Current 0006-0577-61 00006057761 60 TABLET, FILM COATED in 1 BOTTLE (0006-0577-61) 2007-03-30 0000-00-00 No No Current 0006-0577-62 00006057762 180 TABLET, FILM COATED in 1 BOTTLE (0006-0577-62) 2007-03-30 0000-00-00 No No Current 0006-0577-82 00006057782 1000 TABLET, FILM COATED in 1 BOTTLE (0006-0577-82) 2007-03-30 0000-00-00 No No Current