Glipizide

Product NDC
68788-7856
11-digit product format
687887856
Labeler code
68788
Product ID
68788-7856_b7b2f928-04f2-453f-afad-553beea19c0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204720
Marketing category
ANDA
Marketing start
2021-01-29
Substance
GLIPIZIDE
Active strength
10 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 1.

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
A204720-001GLIPIZIDEGLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29
A204720-002GLIPIZIDEGLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29
A204720-003GLIPIZIDEGLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204720-001AB
A204720-002AB
A204720-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204720-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204720-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204720-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204720-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Glipizide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIPIZIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X7WDT95N5CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
315107Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
548c1f50-dbf0-49cc-b58b-fcc5937affa8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09Product name220250625
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7856-1Glipizide100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1006
68788-7856-3Glipizide30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE306
68788-7856-6Glipizide60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE606
68788-7856-9Glipizide90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7856-1EA - Each68788-78565d381e94-1dc1-4927-aec7-c23d18a6ae1112021-03-02
68788-7856-3EA - Each68788-7856483408cf-6829-414e-8380-cd069340224f12021-03-02
68788-7856-6EA - Each68788-7856f7c680ba-adff-4de1-8fdc-40f2bfa401c412021-03-02
68788-7856-9EA - Each68788-785656d8341e-1349-4c5b-b6a5-b84c6aa8359212021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7856GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 4 package rows20240516_548c1f50-dbf0-49cc-b58b-fcc5937affa8.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlipizideGLIPIZIDEREMEDYREPACK INC.03151cb5-d32b-4484-8f2a-8c5d24c7f6f12026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEREMEDYREPACK INC.c2aadc88-22d2-467c-b2cb-03efb5a1f1c12026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEPreferred Pharmaceuticals Inc.548c1f50-dbf0-49cc-b58b-fcc5937affa82026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
ndc (product): 68788-7856
GlipizideGLIPIZIDEPreferred Pharmaceuticals Inc.4632b4ec-d2f1-40cc-8ef4-256413d8dbec2026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEA-S Medication Solutionsa34b58ac-42b2-4a19-a28b-cb3144ea55cd2026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEREMEDYREPACK INC.bde478e6-e290-47e0-9241-ce88d927633e2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDERising Pharma Holdings, Inc.0ffe361a-c99b-4f68-a7e2-a67a71c0c4962026-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDENorthwind Health Company, LLCab2f4ea6-46e8-268a-e053-2995a90a39772026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDENorthwind Health Company, LLCff9b3b7a-5ab1-45ec-e053-6294a90af4262026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEBryant Ranch Prepack0338aff9-29f9-405e-b516-06ef4b8638632024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEA-S Medication Solutions4982f018-c53c-48ec-a4e8-4834228bcf2c2023-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN548c1f50-dbf0-49cc-b58b-fcc5937affa86
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD548c1f50-dbf0-49cc-b58b-fcc5937affa86
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY548c1f50-dbf0-49cc-b58b-fcc5937affa86
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY548c1f50-dbf0-49cc-b58b-fcc5937affa86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7856-168788785601100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7856-1) 2021-01-290000-00-00NoNoCurrent
68788-7856-36878878560330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7856-3) 2021-01-290000-00-00NoNoCurrent
68788-7856-66878878560660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7856-6) 2021-01-290000-00-00NoNoCurrent
68788-7856-96878878560990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7856-9) 2021-01-290000-00-00NoNoCurrent