Home NDC 68071-4857-1 Glipizide
Product NDC 68071-4857
Requested package NDC 68071-4857-1
11-digit product format 680714857
Labeler code 68071
Product ID 68071-4857_2d05cc33-c6ea-86cc-e063-6394a90a3fb7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glipizide
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA075795
Marketing category ANDA
Marketing start 2002-09-25
Substance GLIPIZIDE
Active strength 5 mg/1
Pharmacologic classes Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4857 68071-4857-1 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4857 68071-4857-1 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4857 68071-4857-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A075795-001 GLIPIZIDE GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 A075795-002 GLIPIZIDE GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 88 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 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB RS 2001-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB 2001-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075795-001 GLIPIZIDE 5MG TABLET / ORAL AB 2001-06-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075795-002 GLIPIZIDE 10MG TABLET / ORAL AB 2001-06-13 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLIPIZIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X7WDT95N5C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310490 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4857-1 Glipizide 100 in 1 BOTTLE TABLET 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4857 GLIPIZIDE TABLET [NUCARE PHARMACEUTICALS,INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250202_86e6583c-b290-e2b5-e053-2991aa0ab485.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 2 of 2 · 24 matching rows.
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 68071-4857-1 68071485701 100 TABLET in 1 BOTTLE (68071-4857-1) 100 tablet 2019-04-19 0000-00-00 No No Current