Glipizide

Product NDC: 68382-336
11-digit product format: 683820336
Labeler code: 68382
Product ID: 68382-336_b7eb0015-2bd0-4e12-b35c-e63cd69c5c93
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA203499
Marketing category: ANDA
Marketing start: 2018-07-25
Marketing end: 0000-00-00
Substance: GLIPIZIDE
Active strength: 5 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68382-336		D	Discontinued by firm	2026-08-17
excluded package	package	68382-336	68382-336-01	D	Discontinued by firm	2026-08-17
excluded package	package	68382-336	68382-336-05	D	Discontinued by firm	2026-08-17
excluded package	package	68382-336	68382-336-06	D	Discontinued by firm	2026-08-17
excluded package	package	68382-336	68382-336-10	D	Discontinued by firm	2026-08-17
excluded package	package	68382-336	68382-336-14	D	Discontinued by firm	2026-08-17
excluded package	package	68382-336	68382-336-16	D	Discontinued by firm	2026-08-17
excluded package	package	68382-336	68382-336-77	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-336-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-336-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-336-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-336-77	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-336-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-336-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-336-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-336-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-336-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-336-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-336-77	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-336-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-336-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-336-16	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203499-001	GLIPIZIDE	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16
A203499-002	GLIPIZIDE	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16
A203499-003	GLIPIZIDE	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203499-001	AB
A203499-002	AB
A203499-003	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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203499-002	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203499-003	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203499-001	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203499-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203499-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203499-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203499-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203499-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203499-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203499-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203499-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203499-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203499-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203499-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203499-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203499-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203499-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203499-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203499-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203499-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203499-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203499-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203499-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203499-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203499-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203499-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203499-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203499-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203499-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203499-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203499-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203499-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203499-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203499-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203499-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203499-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203499-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203499-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203499-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203499-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203499-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203499-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203499-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-336-01	EA - Each	68382-336	cedc5eec-d2f4-4e6b-a945-fc995e754be0	1	2018-10-11
68382-336-05	EA - Each	68382-336	162b9753-e27d-4999-8892-8db58939857d	1	2018-10-11

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	e4831ddb-9680-40cb-a060-4ba77c52d0aa	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203499 application number: ANDA203499
Glipizide	GLIPIZIDE	REMEDYREPACK INC.	e593552f-9817-4cb5-b491-31ea57dea4b8	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203499 application number: ANDA203499
Glipizide	GLIPIZIDE	Northstar Rx LLC.	915636a4-092e-4e2e-9bc0-0d387d996977	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203499 application number: ANDA203499
Glipizide	GLIPIZIDE	A-S Medication Solutions	5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c	2023-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203499 application number: ANDA203499
Glipizide	GLIPIZIDE	A-S Medication Solutions	15308fc4-11e3-4cd5-8f04-ab8e3433cc7d	2023-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203499 application number: ANDA203499

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-336-01	68382033601	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-336-01)		2018-07-25	0000-00-00	No	No	Current
68382-336-05	68382033605	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-336-05)		2018-07-25	0000-00-00	No	No	Current
68382-336-06	68382033606	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-336-06)		2018-07-25	0000-00-00	No	No	Current
68382-336-10	68382033610	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-336-10)		2018-07-25	0000-00-00	No	No	Current
68382-336-14	68382033614	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-336-14)		2018-07-25	0000-00-00	No	No	Current
68382-336-16	68382033616	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-336-16)		2018-07-25	0000-00-00	No	No	Current
68382-336-77	68382033677	10 BLISTER PACK in 1 CARTON (68382-336-77) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-336-30)	10 blister pack	2018-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glipizide	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2022-11-09	HUMAN PRESCRIPTION DRUG LABEL	5