Glipizide

Product NDC: 71335-0618
Requested package NDC: 71335-0618-1
11-digit product format: 713350618
Labeler code: 71335
Product ID: 71335-0618_ee9e9c30-e280-4e22-bf55-849abda82186
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075795
Marketing category: ANDA
Marketing start: 2002-09-25
Substance: GLIPIZIDE
Active strength: 10 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075795-001	GLIPIZIDE	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13
A075795-002	GLIPIZIDE	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075795-001	AB
A075795-002	AB

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.

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
2026-08-01 22:54:32	2026-06	A075795-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		2001-06-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075795-002	GLIPIZIDE	10MG	TABLET / ORAL	AB	RS	2001-06-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A075795-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075795-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	376ce3cf-4e1b-4b5f-b3e7-cc9fc4a5aeb4	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	212897cb-7de7-4711-aaf4-44234f950e9f	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	American Health Packaging	ff6805bb-b5f0-46d3-bf1d-3333b63ff1ae	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Coupler LLC	53e650f1-f755-e3ad-e063-6294a90ae309	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Coupler LLC	51b35391-7672-c02f-e063-6294a90af54e	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Cardinal Health 107, LLC	bf1f5a5d-79b0-4fc5-96f2-bd5119b56e2a	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals, Inc.	097424ef-612f-4bc2-809a-e5bb8eeae244	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Major Pharmaceuticals	d3b5677c-2265-47c8-beeb-bf12106056ba	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Legacy Pharmaceutical Packaging, LLC	116ffc6a-735c-49e0-a9d5-69b6bc3e3706	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	A-S Medication Solutions	9c9a3688-6de9-41db-af82-c4aa9b5b3f92	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	f60b0690-aca9-40ec-956e-bd2ecc35ec54	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	A-S Medication Solutions	383540fd-2931-49bf-8009-25e8f7fc9bda	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	A-S Medication Solutions	a38cfe61-4aa5-498c-bca5-03a8213303bb	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	0ed5ed22-dd53-495d-bc10-0bede4d87926	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	6282c653-9e9c-6810-e053-2991aa0a4a8e	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	AvPAK	aa1b16bf-e01c-d539-e053-2995a90a2735	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	c16edad6-4271-6ff0-e053-2a95a90a0240	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	A-S Medication Solutions	16fb8bc7-1db1-477e-a201-b3b678b8a84c	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	1b2e5656-9da9-4fab-bf01-ed75896b836a	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795
Glipizide	GLIPIZIDE	Apotex Corp.	dcf426b8-bcdc-8214-a1b6-6388bd3399a0	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075795 application number: ANDA075795

Additional Listing Data#

Finished product: Yes
Brand name base: Glipizide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLIPIZIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X7WDT95N5C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310488	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
4995328f-287c-4d4a-9b5f-9d354cc530fb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09	Product name	2	20250625
b1de1ca9-d9db-4f4b-2103-09e2014d30d5	Product name	5	20180912
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0618-1	Glipizide	60 in 1 BOTTLE	TABLET	60	8
71335-0618-2	Glipizide	30 in 1 BOTTLE	TABLET	30	8
71335-0618-3	Glipizide	100 in 1 BOTTLE	TABLET	100	8
71335-0618-4	Glipizide	120 in 1 BOTTLE	TABLET	120	8
71335-0618-5	Glipizide	90 in 1 BOTTLE	TABLET	90	8
71335-0618-6	Glipizide	20 in 1 BOTTLE	TABLET	20	8
71335-0618-7	Glipizide	180 in 1 BOTTLE	TABLET	180	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0618-1	EA - Each	71335-0618	58311ba4-54b8-407f-8260-ae8f55f9b946	1	2022-11-07
71335-0618-2	EA - Each	71335-0618	23f6794c-67b0-4b79-8899-0278415539a0	1	2022-11-07
71335-0618-5	EA - Each	71335-0618	9da5004f-5873-4470-b376-392dab8df4a0	1	2022-11-07
71335-0618-7	EA - Each	71335-0618	a4a043f8-2bd4-4153-b83e-0db3faae449d	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0618	GLIPIZIDE TABLET [BRYANT RANCH PREPACK]	8	Current NDC, Legacy NDC, 7 package rows	20241025_4995328f-287c-4d4a-9b5f-9d354cc530fb.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X7WDT95N5C	GLIPIZIDE	29094-61-9	GLIPIZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310488	glipiZIDE 10 MG Oral Tablet	PSN	4995328f-287c-4d4a-9b5f-9d354cc530fb	8
310488	glipizide 10 MG Oral Tablet	SCD	4995328f-287c-4d4a-9b5f-9d354cc530fb	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0618-1	71335061801	60 TABLET in 1 BOTTLE (71335-0618-1)	60 tablet	2018-03-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only	Bryant Ranch Prepack	2024-10-08	HUMAN PRESCRIPTION DRUG LABEL	8