Home NDC 70518-0373 Glipizide and Metformin Hydrochloride
Product NDC 70518-0373
11-digit product format 705180373
Labeler code 70518
Product ID 70518-0373_5c146e7a-0576-f0cf-e063-6394a90a661d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glipizide and Metformin Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA077270
Marketing category ANDA
Marketing start 2017-04-03
Substance GLIPIZIDE; METFORMIN HYDROCHLORIDE
Active strength 5; 500 mg/1; mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 A077270-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2005-10-28 A077270-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE GLIPIZIDE; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB RS 2005-10-28
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.
Product history page 1 of 4 · 132 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 2026-10-15 13:18:30 2026-09 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077270-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2005-10-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077270-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB RS 2005-10-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077270-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2005-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077270-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB RS 2005-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077270-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2005-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077270-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB RS 2005-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077270-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2005-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077270-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB RS 2005-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077270-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2005-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077270-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB RS 2005-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077270-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2005-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077270-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB RS 2005-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077270-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2005-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077270-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB RS 2005-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077270-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2005-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077270-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB RS 2005-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077270-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2005-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077270-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB RS 2005-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077270-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2005-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077270-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB RS 2005-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077270-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2005-10-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077270-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB RS 2005-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077270-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2005-10-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077270-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB RS 2005-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077270-002 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;500MG TABLET / ORAL AB 2005-10-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077270-003 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL AB RS 2005-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077270-001 GLIPIZIDE AND METFORMIN HYDROCHLORIDE 2.5MG;250MG TABLET / ORAL AB 2005-10-28 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 4 · 132 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 Glipizide and Metformin Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLIPIZIDE 5 mg/1 METFORMIN HYDROCHLORIDE 500 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-0373-0 Glipizide and Metformin Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 13 70518-0373-1 Glipizide and Metformin Hydrochloride 180 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 180 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-0373 GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] 10 Current NDC, Legacy NDC, 2 package rows 20250523_3f2599c6-9e33-487e-9379-6477bb121461.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70518-0373-0 70518037300 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0373-0) 2017-04-03 0000-00-00 No No Current 70518-0373-1 70518037301 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0373-1) 2017-04-03 0000-00-00 No No Current