Glipizide

Product NDC
72789-464
Requested package NDC
72789-464-95
11-digit product format
727890464
Labeler code
72789
Product ID
72789-464_57ecbb16-a3f0-4ec2-e063-6394a90a7748
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA214874
Marketing category
ANDA
Marketing start
2023-10-03
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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214874-001GLIPIZIDEGLIPIZIDE2.5MGTABLET / ORAL2023-10-03
A214874-002GLIPIZIDEGLIPIZIDE5MGTABLET / ORALAB2023-10-03
A214874-003GLIPIZIDEGLIPIZIDE10MGTABLET / ORALAB2023-10-03
A214874-004GLIPIZIDEGLIPIZIDE15MGTABLET / ORALRS2026-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214874-002AB
A214874-003AB

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 2 · 70 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A214874-001GLIPIZIDE2.5MGTABLET / ORAL2023-10-0384e616aacf4f…
2026-09-14 22:38:342026-08A214874-002GLIPIZIDE5MGTABLET / ORALAB2023-10-0384e616aacf4f…
2026-09-14 22:38:342026-08A214874-003GLIPIZIDE10MGTABLET / ORALAB2023-10-0384e616aacf4f…
2026-09-14 22:38:342026-08A214874-004GLIPIZIDE15MGTABLET / ORALRS2026-02-0484e616aacf4f…
2026-08-18 06:07:402026-07A214874-001GLIPIZIDE2.5MGTABLET / ORAL2023-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A214874-002GLIPIZIDE5MGTABLET / ORALAB2023-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A214874-003GLIPIZIDE10MGTABLET / ORALAB2023-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A214874-004GLIPIZIDE15MGTABLET / ORALRS2026-02-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214874-001GLIPIZIDE2.5MGTABLET / ORAL2023-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214874-002GLIPIZIDE5MGTABLET / ORALAB2023-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214874-003GLIPIZIDE10MGTABLET / ORALAB2023-10-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214874-004GLIPIZIDE15MGTABLET / ORALRS2026-02-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214874-001GLIPIZIDE2.5MGTABLET / ORAL2023-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214874-002GLIPIZIDE5MGTABLET / ORALAB2023-10-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214874-003GLIPIZIDE10MGTABLET / ORALAB2023-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A214874-001GLIPIZIDE2.5MGTABLET / ORAL2023-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214874-002GLIPIZIDE5MGTABLET / ORALAB2023-10-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214874-003GLIPIZIDE10MGTABLET / ORALAB2023-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214874-001GLIPIZIDE2.5MGTABLET / ORAL2023-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214874-002GLIPIZIDE5MGTABLET / ORALAB2023-10-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214874-003GLIPIZIDE10MGTABLET / ORALAB2023-10-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214874-001GLIPIZIDE2.5MGTABLET / ORAL2023-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214874-002GLIPIZIDE5MGTABLET / ORALAB2023-10-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214874-003GLIPIZIDE10MGTABLET / ORALAB2023-10-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214874-001GLIPIZIDE2.5MGTABLET / ORAL2023-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214874-002GLIPIZIDE5MGTABLET / ORALAB2023-10-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214874-003GLIPIZIDE10MGTABLET / ORALAB2023-10-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214874-001GLIPIZIDE2.5MGTABLET / ORAL2023-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214874-002GLIPIZIDE5MGTABLET / ORALAB2023-10-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214874-003GLIPIZIDE10MGTABLET / ORALAB2023-10-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214874-001GLIPIZIDE2.5MGTABLET / ORAL2023-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214874-002GLIPIZIDE5MGTABLET / ORALAB2023-10-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214874-003GLIPIZIDE10MGTABLET / ORALAB2023-10-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214874-001GLIPIZIDE2.5MGTABLET / ORAL2023-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214874-002GLIPIZIDE5MGTABLET / ORALAB2023-10-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214874-003GLIPIZIDE10MGTABLET / ORALAB2023-10-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214874-001GLIPIZIDE2.5MGTABLET / ORAL2023-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A214874-002GLIPIZIDE5MGTABLET / ORALAB2023-10-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A214874-003GLIPIZIDE10MGTABLET / ORALAB2023-10-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214874-001GLIPIZIDE2.5MGTABLET / ORAL2023-10-0379d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A214874-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A214874-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A214874-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214874-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214874-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214874-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214874-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214874-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214874-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214874-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214874-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214874-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214874-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214874-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214874-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214874-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214874-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214874-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214874-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214874-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214874-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214874-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214874-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214874-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214874-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214874-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214874-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214874-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214874-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214874-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214874-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214874-003AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214874-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214874-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214874-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214874-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214874-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A214874-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214874-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214874-003AB1a72a2bbeb626…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214874-001CGT2024-04-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214874-001CGT2024-04-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214874-001CGT2024-04-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214874-001CGT2024-04-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214874-001CGT2024-04-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214874-001CGT2024-04-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214874-001CGT2024-04-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214874-001CGT2024-04-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214874-001CGT2024-04-158072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214874-001CGT2024-04-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214874-001CGT2024-04-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214874-001CGT2024-04-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214874-001CGT2024-04-15a72a2bbeb626…

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

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
310490Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3de8b0a7-b848-40af-8406-fe6924ff41dbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09Product name220250625
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-464-86Glipizide360 in 1 BOTTLE, PLASTICTABLET3607
72789-464-90Glipizide90 in 1 BOTTLE, PLASTICTABLET907
72789-464-93Glipizide180 in 1 BOTTLE, PLASTICTABLET1807
72789-464-95Glipizide1000 in 1 BOTTLE, PLASTICTABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-464-86EA - Each72789-464d1a8765d-e0b5-4a2e-bd52-88e539d4c24412026-03-17
72789-464-90EA - Each72789-464eef50743-f41b-4308-bb21-4a0edc723a1b12025-02-10
72789-464-93EA - Each72789-46454b5bf09-b77b-48fa-9377-323513f1412612025-02-10
72789-464-95EA - Each72789-464fa2d110a-bd9c-4a5e-9816-f9742d4d02f912025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-464GLIPIZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]4Current NDC, 4 package rows20241225_3de8b0a7-b848-40af-8406-fe6924ff41db.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlipizideGLIPIZIDEPD-Rx Pharmaceuticals, Inc.d9b6464f-6fe6-446e-8150-d0c15c46fee82026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874
GlipizideGLIPIZIDEPD-Rx Pharmaceuticals, Inc.3de8b0a7-b848-40af-8406-fe6924ff41db2026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874
ndc (package): 72789-464-95
ndc (product): 72789-464
ndc11 (package): 72789046495
GlipizideGLIPIZIDENuCare Pharmaceuticals, Inc.4c4dfe64-d1c5-65ec-e063-6394a90aead52026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874
GlipizideGLIPIZIDEBryant Ranch Prepack06fb6c56-5609-41d9-8389-eba81432218d2026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874
GlipizideGLIPIZIDEBryant Ranch Prepack5ca7e38b-84cb-4043-b97e-e2f5cd82b4422026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874
GlipizideGLIPIZIDEPD-Rx Pharmaceuticals, Inc.c8cfd137-7b41-460f-a463-141c9d1985ff2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874
GlipizideGLIPIZIDEA-S Medication Solutions69a21bd3-3364-4035-b098-3808cc8cf8b22026-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874
GlipizideGLIPIZIDEA-S Medication Solutionsc582d7d0-4db0-4296-8131-baefd1a671b22026-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874
GlipizideGLIPIZIDEAdvagen Pharma Limitede954afb8-52eb-416a-8f1b-14b0fcb3bac22026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874
GlipizideGLIPIZIDEA-S Medication Solutions3b111484-78ef-4db9-95ee-6cc4b6acdd592025-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874
GlipizideGLIPIZIDEA-S Medication Solutions155216cf-4bad-479a-83b6-032d4bd11c2e2025-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874
GlipizideGLIPIZIDEAdvanced Rx of Tennessee, LLC3d87cc75-7a0d-46a2-e063-6294a90a6d492025-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874
GlipizideGLIPIZIDEPreferred Pharmaceuticals Inc.4d490a3a-abdc-4ff4-83fb-f302f51e30232025-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874
GlipizideGLIPIZIDEProficient Rx LP6427db20-6783-439f-8c2d-64d1a6fcb9fc2025-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874
GlipizideGLIPIZIDETruPharma LLC95ea4c96-84b9-4515-9494-a93d26820f702023-10-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214874
application number: ANDA214874

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310490glipiZIDE 5 MG Oral TabletPSN3de8b0a7-b848-40af-8406-fe6924ff41db7
310490glipizide 5 MG Oral TabletSCD3de8b0a7-b848-40af-8406-fe6924ff41db7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-464-95727890464951000 TABLET in 1 BOTTLE, PLASTIC (72789-464-95) 1000 tablet2024-12-23NoNoCurrent