Home NDC 53002-4460 Glipizide
Product NDC 53002-4460
11-digit product format 530024460
Labeler code 53002
Product ID 53002-4460_76a0cb91-c019-4ca5-8b00-d9929462020d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glipizide
Dosage form TABLET
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
Application ANDA074550
Marketing category ANDA
Marketing start 2011-07-18
Marketing end 0000-00-00
Substance GLIPIZIDE
Active strength 5 mg/1
Pharmacologic classes Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53002-4460-6 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53002-4460-3 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53002-4460-0 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53002-4460-6 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53002-4460-3 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53002-4460-0 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53002-4460-6 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53002-4460-3 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53002-4460-0 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53002-4460-6 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53002-4460-3 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53002-4460-0 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53002-4460-6 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53002-4460-3 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53002-4460-0 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53002-4460-6 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53002-4460-3 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53002-4460-0 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53002-4460-0 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53002-4460-3 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53002-4460-6 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53002-4460-0 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53002-4460-3 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53002-4460-6 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53002-4460-0 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53002-4460-3 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53002-4460-6 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53002-4460-6 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53002-4460-0 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53002-4460-3 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53002-4460-3 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53002-4460-6 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53002-4460-0 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A074550-001 GLIPIZIDE GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 A074550-002 GLIPIZIDE GLIPIZIDE 10MG TABLET / ORAL 1997-09-11
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 · 84 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 2026-08-18 06:07:40 2026-07 A074550-001 GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074550-002 GLIPIZIDE 10MG TABLET / ORAL 1997-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074550-001 GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074550-002 GLIPIZIDE 10MG TABLET / ORAL 1997-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074550-001 GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074550-002 GLIPIZIDE 10MG TABLET / ORAL 1997-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074550-001 GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074550-002 GLIPIZIDE 10MG TABLET / ORAL 1997-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074550-001 GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074550-002 GLIPIZIDE 10MG TABLET / ORAL 1997-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074550-001 GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074550-002 GLIPIZIDE 10MG TABLET / ORAL 1997-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074550-001 GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074550-002 GLIPIZIDE 10MG TABLET / ORAL 1997-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074550-001 GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074550-002 GLIPIZIDE 10MG TABLET / ORAL 1997-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074550-001 GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074550-002 GLIPIZIDE 10MG TABLET / ORAL 1997-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074550-001 GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074550-002 GLIPIZIDE 10MG TABLET / ORAL 1997-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074550-001 GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074550-002 GLIPIZIDE 10MG TABLET / ORAL 1997-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074550-001 GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074550-002 GLIPIZIDE 10MG TABLET / ORAL 1997-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074550-001 GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074550-002 GLIPIZIDE 10MG TABLET / ORAL 1997-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074550-001 GLIPIZIDE 5MG TABLET / ORAL 1997-09-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074550-002 GLIPIZIDE 10MG TABLET / ORAL 1997-09-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074550-001 GLIPIZIDE 5MG TABLET / ORAL AB 1997-09-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074550-002 GLIPIZIDE 10MG TABLET / ORAL AB 1997-09-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074550-001 GLIPIZIDE 5MG TABLET / ORAL AB 1997-09-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074550-002 GLIPIZIDE 10MG TABLET / ORAL AB 1997-09-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074550-001 GLIPIZIDE 5MG TABLET / ORAL AB 1997-09-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074550-002 GLIPIZIDE 10MG TABLET / ORAL AB 1997-09-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074550-001 GLIPIZIDE 5MG TABLET / ORAL AB 1997-09-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074550-002 GLIPIZIDE 10MG TABLET / ORAL AB 1997-09-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074550-001 GLIPIZIDE 5MG TABLET / ORAL AB 1997-09-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074550-002 GLIPIZIDE 10MG TABLET / ORAL AB 1997-09-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074550-001 GLIPIZIDE 5MG TABLET / ORAL AB 1997-09-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074550-002 GLIPIZIDE 10MG TABLET / ORAL AB 1997-09-11 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 53002-4460-0 2025-01-30 GLIPIZIDE TABLETS, USP 53002-4460-3 2025-01-30 GLIPIZIDE TABLETS, USP 53002-4460-6 2025-01-30 GLIPIZIDE TABLETS, USP 53002-4460-0 2023-06-07 GLIPIZIDE TABLETS, USP 53002-4460-3 2023-06-07 GLIPIZIDE TABLETS, USP 53002-4460-6 2023-06-07 GLIPIZIDE TABLETS, USP 53002-4460-0 2023-01-30 GLIPIZIDE TABLETS, USP 53002-4460-3 2023-01-30 GLIPIZIDE TABLETS, USP 53002-4460-6 2023-01-30 GLIPIZIDE TABLETS, USP 53002-4460-0 2020-12-16 GLIPIZIDE TABLETS, USP 53002-4460-3 2020-12-16 GLIPIZIDE TABLETS, USP 53002-4460-6 2020-12-16 GLIPIZIDE TABLETS, USP 53002-4460-0 2020-01-31 GLIPIZIDE TABLETS, USP 53002-4460-3 2020-01-31 GLIPIZIDE TABLETS, USP 53002-4460-6 2020-01-31 GLIPIZIDE TABLETS, USP
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53002-4460-0 Glipizide 100 in 1 BOTTLE TABLET 100 7 53002-4460-3 Glipizide 30 in 1 BOTTLE TABLET 30 7 53002-4460-6 Glipizide 60 in 1 BOTTLE TABLET 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-4460 GLIPIZIDE TABLET [RPK PHARMACEUTICALS, INC.] 7 Legacy NDC, 3 package rows 20230609_a98b2568-0ce3-4c80-a1aa-a0bf5884564a.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 53002-4460-0 53002446000 100 TABLET in 1 BOTTLE (53002-4460-0) 100 tablet 2017-10-01 0000-00-00 No No Current 53002-4460-3 53002446003 30 TABLET in 1 BOTTLE (53002-4460-3) 30 tablet 2017-10-01 0000-00-00 No No Current 53002-4460-6 53002446006 60 TABLET in 1 BOTTLE (53002-4460-6) 60 tablet 2017-10-01 0000-00-00 No No Current