Glipizide

Product NDC: 55289-301
11-digit product format: 552890301
Labeler code: 55289
Product ID: 55289-301_d9a625e0-7363-590f-e053-2995a90a15ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glipizide
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA076467
Marketing category: ANDA
Marketing start: 2003-11-19
Marketing end: 0000-00-00
Substance: GLIPIZIDE
Active strength: 10 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55289-301		D	Discontinued by firm	2026-08-17
excluded package	package	55289-301	55289-301-90	D	Discontinued by firm	2026-08-17
excluded package	package	55289-301	55289-301-93	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 · 6 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	55289-301-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55289-301-90	`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	55289-301-93	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55289-301-90	`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
A076467-001	GLIPIZIDE	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08
A076467-002	GLIPIZIDE	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-11-07
A076467-003	GLIPIZIDE	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076467-001	AB
A076467-002	AB
A076467-003	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	A076467-001	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076467-002	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076467-003	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076467-001	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076467-002	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076467-003	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076467-001	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076467-002	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076467-003	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076467-001	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076467-002	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076467-003	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076467-001	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076467-002	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076467-003	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076467-001	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076467-002	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076467-003	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076467-001	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076467-002	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076467-003	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076467-001	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076467-002	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076467-003	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076467-001	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076467-002	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076467-003	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076467-001	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076467-002	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076467-003	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076467-001	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076467-002	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076467-003	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076467-001	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076467-002	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-11-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076467-003	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076467-001	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076467-002	GLIPIZIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-11-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076467-003	GLIPIZIDE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076467-001	GLIPIZIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-09-08	`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	A076467-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076467-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076467-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076467-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076467-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076467-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076467-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076467-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076467-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076467-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076467-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076467-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076467-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076467-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076467-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076467-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076467-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076467-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076467-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076467-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076467-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076467-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076467-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076467-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076467-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076467-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076467-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076467-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076467-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076467-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076467-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076467-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076467-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076467-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076467-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076467-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076467-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076467-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076467-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076467-001	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
55289-301-90	EA - Each	55289-301	a92a3863-239b-4cca-92ac-83c5d8d64aa3	1	2015-05-05
55289-301-93	EA - Each	55289-301	b111f69a-23c1-4377-9370-383f49bc0e6b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLIPIZIDE	ACTIVE INGREDIENT	X7WDT95N5C	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8
GLIPIZIDE	ACTIVE MOIETY	X7WDT95N5C	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8
ACETYLTRIBUTYL CITRATE	INACTIVE INGREDIENT	0ZBX0N59RZ	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55289-301	GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	24	Legacy NDC	20250504_42308dd9-57c2-4416-a394-681f6733f566.zip

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	Marketing start	Marketing end	Sample	Exclude flag	Status
55289-301-90	55289030190	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-301-90)	2011-03-18	0000-00-00	No	No	Current
55289-301-93	55289030193	180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-301-93)	2011-03-18	0000-00-00	No	No	Current