FDA.reportPublic FDA data

Glipizide

Product NDC
11788-120
11-digit product format
117880120
Labeler code
11788
Product ID
11788-120_a60bf08d-80c5-4145-9a22-e08e424f1f95
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
2.5 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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 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

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

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

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-04-04 05:41 UTC2022-04A074305-002GLIPIZIDE10MGTABLET / ORALAB1995-04-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074305-001GLIPIZIDE5MGTABLET / ORALAB1995-04-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074305-002GLIPIZIDE10MGTABLET / ORALAB1995-04-0774a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A074305-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A074305-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A074305-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074305-002AB1caaa826d4ba7…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074305-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074305-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074305-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074305-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074305-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074305-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074305-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074305-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074305-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074305-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074305-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074305-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074305-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074305-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074305-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A074305-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074305-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074305-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074305-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A074305-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074305-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A074305-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074305-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A074305-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074305-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A074305-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074305-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A074305-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074305-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A074305-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074305-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074305-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074305-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A074305-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074305-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A074305-002AB1ea1830bbd6c7…

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
GLIPIZIDE2.5 mg/1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11788-120-0111788012001100 TABLET in 1 BOTTLE (11788-120-01) 100 tablet2026-10-09NoNoCurrent
11788-120-0511788012005500 TABLET in 1 BOTTLE (11788-120-05) 500 tablet2026-10-09NoNoCurrent
11788-120-10117880120101000 TABLET in 1 BOTTLE (11788-120-10) 1000 tablet2026-10-09NoNoCurrent