Glipizide

Product NDC: 68788-8138
Requested package NDC: 68788-8138-8
11-digit product format: 687888138
Labeler code: 68788
Product ID: 68788-8138_a2c8fccf-2431-4e3e-ba37-920df8ea189b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc..
Application: ANDA074223
Marketing category: ANDA
Marketing start: 2022-02-11
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074223-001	GLIPIZIDE	GLIPIZIDE	5MG	TABLET / ORAL	AB		1995-02-27
A074223-002	GLIPIZIDE	GLIPIZIDE	10MG	TABLET / ORAL	AB		1995-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074223-001	AB
A074223-002	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	A074223-001	GLIPIZIDE	5MG	TABLET / ORAL	AB		1995-02-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074223-002	GLIPIZIDE	10MG	TABLET / ORAL	AB		1995-02-27	`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	A074223-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074223-002	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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc..	02857195-33e9-4c1f-9e5f-7cc62f283649	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223 ndc (package): 68788-8138-8 ndc (product): 68788-8138 ndc11 (package): 68788813808
Glipizide	GLIPIZIDE	Preferred Pharmaceuticals Inc.	65ddb8b3-19d4-482f-8aec-49dc167a4c40	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	A-S Medication Solutions	99af53db-e102-427a-a5a2-be1e69b3152d	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	Northwind Health Company, LLC	3bb3b80a-30e8-62fe-e054-00144ff8d46c	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	PD-Rx Pharmaceuticals, Inc.	c829b7bf-1a12-44b2-b5ce-fd44a1f0d333	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	Proficient Rx LP	d5398166-5698-4ee5-bd41-3c24e4445b53	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	5c627a52-e4ca-7103-e053-2a91aa0ae13f	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	A-S Medication Solutions	b31ab6dd-0277-43ee-a054-f20c462f0c56	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	Bryant Ranch Prepack	afb65cc1-a4fb-4771-b09c-dcf6e8c5786e	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	589dc76d-c347-0589-e053-2991aa0a2520	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	8c27962d-626b-30e6-e053-2a95a90a49c6	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	NuCare Pharmaceuticals,Inc.	7c21db4d-6b9b-36c3-e053-2991aa0a0fd9	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	Actavis Pharma, Inc.	ad55dfd7-ffb5-478a-aa84-1009fa921e22	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	A-S Medication Solutions	0874340a-75a1-4ac9-b224-80c5c24e1b41	2023-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	NCS HealthCare of KY, LLC dba Vangard Labs	bf5ff427-3ee4-4064-a55e-35daa2f12a06	2023-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223
Glipizide	GLIPIZIDE	Aphena Pharma Solutions - Tennessee, LLC	d6c016f7-bf93-4322-a179-d4798234b381	2017-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074223 application number: ANDA074223

Additional Listing Data#

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

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
02857195-33e9-4c1f-9e5f-7cc62f283649	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
68788-8138-1	Glipizide	100 in 1 BOTTLE, PLASTIC	TABLET	100	5
68788-8138-3	Glipizide	30 in 1 BOTTLE, PLASTIC	TABLET	30	5
68788-8138-6	Glipizide	60 in 1 BOTTLE, PLASTIC	TABLET	60	5
68788-8138-8	Glipizide	180 in 1 BOTTLE, PLASTIC	TABLET	180	5
68788-8138-9	Glipizide	90 in 1 BOTTLE, PLASTIC	TABLET	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8138-1	EA - Each	68788-8138	36e2282e-742e-40f9-9823-d59a77fd6afd	1	2022-03-09
68788-8138-3	EA - Each	68788-8138	18af44bd-7a9c-4082-a128-1c425f707340	1	2022-03-09
68788-8138-6	EA - Each	68788-8138	fa7628f1-0ec4-4537-9d81-c02ec9c22eb3	1	2022-03-09
68788-8138-8	EA - Each	68788-8138	12e28a42-cde5-4be6-9389-908cc0b00965	1	2022-03-09
68788-8138-9	EA - Each	68788-8138	7e157b82-8e1c-4e18-8099-080c868de7f7	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8138	GLIPIZIDE TABLET [PREFERRED PHARMACEUTICALS INC..]	3	Current NDC, Legacy NDC, 5 package rows	20240516_02857195-33e9-4c1f-9e5f-7cc62f283649.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	02857195-33e9-4c1f-9e5f-7cc62f283649	5
310488	glipizide 10 MG Oral Tablet	SCD	02857195-33e9-4c1f-9e5f-7cc62f283649	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8138-8	68788813808	180 TABLET in 1 BOTTLE, PLASTIC (68788-8138-8)	180 tablet	2022-02-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
glipiZIDE Tablets, USP for oral use Rx only	Preferred Pharmaceuticals Inc..	2026-05-07	HUMAN PRESCRIPTION DRUG LABEL	5