Glipizide

Product NDC
11788-117
11-digit product format
117880117
Labeler code
11788
Product ID
11788-117_24c6a4a3-d498-4170-b66d-d76c0506c10d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
ANDA074305
Marketing category
ANDA
Marketing start
2026-10-09
Substance
GLIPIZIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074305-001GLIPIZIDEGLIPIZIDE5MGTABLET / ORALAB1995-04-07
A074305-002GLIPIZIDEGLIPIZIDE10MGTABLET / ORALAB1995-04-07
A074305-003GLIPIZIDEGLIPIZIDE2.5MGTABLET / ORALAB2026-09-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A074305-001AB
A074305-002AB
A074305-003AB

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 · 89 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A074305-001GLIPIZIDE5MGTABLET / ORALAB1995-04-07c2088c7a36db…
2026-10-15 13:18:302026-09A074305-002GLIPIZIDE10MGTABLET / ORALAB1995-04-07c2088c7a36db…
2026-10-15 13:18:302026-09A074305-003GLIPIZIDE2.5MGTABLET / ORALAB2026-09-23c2088c7a36db…
2026-09-14 22:38:342026-08A074305-001GLIPIZIDE5MGTABLET / ORALAB1995-04-0784e616aacf4f…
2026-09-14 22:38:342026-08A074305-002GLIPIZIDE10MGTABLET / ORALAB1995-04-0784e616aacf4f…
2026-08-18 06:07:402026-07A074305-001GLIPIZIDE5MGTABLET / ORALAB1995-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07A074305-002GLIPIZIDE10MGTABLET / ORALAB1995-04-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074305-001GLIPIZIDE5MGTABLET / ORAL1995-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074305-002GLIPIZIDE10MGTABLET / ORAL1995-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074305-001GLIPIZIDE5MGTABLET / ORAL1995-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074305-002GLIPIZIDE10MGTABLET / ORAL1995-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074305-001GLIPIZIDE5MGTABLET / ORAL1995-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074305-002GLIPIZIDE10MGTABLET / ORAL1995-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074305-001GLIPIZIDE5MGTABLET / ORAL1995-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074305-002GLIPIZIDE10MGTABLET / ORAL1995-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074305-001GLIPIZIDE5MGTABLET / ORAL1995-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074305-002GLIPIZIDE10MGTABLET / ORAL1995-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074305-001GLIPIZIDE5MGTABLET / ORAL1995-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074305-002GLIPIZIDE10MGTABLET / ORAL1995-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074305-001GLIPIZIDE5MGTABLET / ORAL1995-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074305-002GLIPIZIDE10MGTABLET / ORAL1995-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074305-001GLIPIZIDE5MGTABLET / ORAL1995-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074305-002GLIPIZIDE10MGTABLET / ORAL1995-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074305-001GLIPIZIDE5MGTABLET / ORAL1995-04-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074305-002GLIPIZIDE10MGTABLET / ORAL1995-04-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074305-001GLIPIZIDE5MGTABLET / ORAL1995-04-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A074305-002GLIPIZIDE10MGTABLET / ORAL1995-04-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074305-001GLIPIZIDE5MGTABLET / ORAL1995-04-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074305-002GLIPIZIDE10MGTABLET / ORAL1995-04-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074305-001GLIPIZIDE5MGTABLET / ORAL1995-04-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074305-002GLIPIZIDE10MGTABLET / ORAL1995-04-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074305-001GLIPIZIDE5MGTABLET / ORALAB1995-04-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074305-002GLIPIZIDE10MGTABLET / ORALAB1995-04-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074305-001GLIPIZIDE5MGTABLET / ORALAB1995-04-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074305-002GLIPIZIDE10MGTABLET / ORALAB1995-04-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074305-001GLIPIZIDE5MGTABLET / ORALAB1995-04-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074305-002GLIPIZIDE10MGTABLET / ORALAB1995-04-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074305-001GLIPIZIDE5MGTABLET / ORALAB1995-04-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074305-002GLIPIZIDE10MGTABLET / ORALAB1995-04-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074305-001GLIPIZIDE5MGTABLET / ORALAB1995-04-074b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 63 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-02-18 07:12 UTC2024-02A074305-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074305-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A074305-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074305-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074305-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074305-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074305-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074305-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074305-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074305-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074305-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074305-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A074305-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074305-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A074305-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074305-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074305-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074305-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A074305-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074305-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A074305-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074305-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074305-002AB1cb3db0bc1861…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIPIZIDE5 mg/1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11788-117-001178801170071400 TABLET in 1 CASE (11788-117-00) 71400 tablet2026-10-09NoNoCurrent
11788-117-0111788011701100 TABLET in 1 BOTTLE (11788-117-01) 100 tablet2026-10-09NoNoCurrent
11788-117-0511788011705500 TABLET in 1 BOTTLE (11788-117-05) 500 tablet2026-10-09NoNoCurrent
11788-117-10117880117101000 TABLET in 1 BOTTLE (11788-117-10) 1000 tablet2026-10-09NoNoCurrent