Home NDC 72205-409 Linagliptin and metformin hydrochloride
Product NDC 72205-409
11-digit product format 722050409
Labeler code 72205
Product ID 72205-409_5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Linagliptin and metformin hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA208459
Marketing category ANDA
Marketing start 2025-11-03
Substance LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Active strength 2.5; 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 2026-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208459-001 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2025-11-03 A208459-002 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;850MG TABLET / ORAL AB 2025-11-03 A208459-003 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET / ORAL AB 2025-11-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2026-09-14 22:38:34 2026-08 A208459-001 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2025-11-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208459-002 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;850MG TABLET / ORAL AB 2025-11-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208459-003 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET / ORAL AB 2025-11-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208459-001 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2025-11-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208459-002 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;850MG TABLET / ORAL AB 2025-11-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208459-003 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET / ORAL AB 2025-11-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208459-001 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2025-11-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208459-002 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;850MG TABLET / ORAL AB 2025-11-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208459-003 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET / ORAL AB 2025-11-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208459-001 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2025-11-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208459-002 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;850MG TABLET / ORAL AB 2025-11-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208459-003 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET / ORAL AB 2025-11-03 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208459-001 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2025-11-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208459-002 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;850MG TABLET / ORAL AB 2025-11-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208459-003 LINAGLIPTIN AND METFORMIN HYDROCHLORIDE 2.5MG;1GM TABLET / ORAL AB 2025-11-03 a50c72e98297…
Observed Orange Book normalized TE history# 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 Linagliptin and metformin hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LINAGLIPTIN 2.5 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 786Z46389E Internal UNII lookup 3X29ZEJ4R2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1243020 Internal RxNorm lookup 1243027 Internal RxNorm lookup 1243034 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 72205-409-01 Linagliptin and metformin hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 1 72205-409-02 Linagliptin and metformin hydrochloride 180 in 1 BOTTLE TABLET, FILM COATED 180 1
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 · 1 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 72205-409-01 72205040901 60 TABLET, FILM COATED in 1 BOTTLE (72205-409-01) 2025-11-04 No No Current 72205-409-02 72205040902 180 TABLET, FILM COATED in 1 BOTTLE (72205-409-02) 2025-11-04 No No Current