Glimepiride

Product NDC: 16729-003
11-digit product format: 167290003
Labeler code: 16729
Product ID: 16729-003_415deb6c-47dc-ed2a-e063-6394a90a66fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: Accord Healthcare Inc
Application: ANDA078181
Marketing category: ANDA
Marketing start: 2007-08-23
Substance: GLIMEPIRIDE
Active strength: 4 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078181-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23
A078181-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23
A078181-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078181-001	AB
A078181-002	AB
A078181-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`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	A078181-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078181-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078181-003	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	9e863f84-d6f2-4d61-8250-774569e84353	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	58c4261e-e98f-4280-9562-2800956dff14	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	1b3c7d74-f80b-4fb1-8dca-66880af5d3fc	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	3e81a39a-30bb-4d6d-82e1-17d7134365be	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	f2f2d6da-eb40-4290-e053-2a95a90a6ca0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Accord Healthcare Inc	9b74fbac-9e04-4927-9981-1e3dace89c6d	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181 ndc (product): 16729-003
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	beb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	5a5747ea-cded-49ed-8807-dd3e2a1159e0	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	68cb4fcd-5bc3-4f53-9085-86df6a4246d6	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078181 application number: ANDA078181

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLIMEPIRIDE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6KY687524K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199245	Internal RxNorm lookup
199246	Internal RxNorm lookup
199247	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
9b74fbac-9e04-4927-9981-1e3dace89c6d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b890b964-2cf0-4439-aaf3-900c9e3e9e49	Product name	1	20160602
7611093e-8875-33d4-9e3c-f48c7e3af1e8	Product name	1	20140508
d36d861f-8a90-80cc-8935-1e6be9b4c7eb	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-003-01	Glimepiride	100 in 1 BOTTLE	TABLET	100	10
16729-003-16	Glimepiride	500 in 1 BOTTLE	TABLET	500	10
16729-003-17	Glimepiride	1000 in 1 BOTTLE	TABLET	1000	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-003-01	EA - Each	16729-003	0076d1ca-2a13-4bfb-98ee-17258bd8f77a	1	2013-02-13
16729-003-16	EA - Each	16729-003	f401dc9e-e474-41a4-b426-cd34551a4dc8	1	2016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]	4
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]	4
glimepiride	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [PROFICIENT RX LP]	1
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS]	1
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS]	1
glimepiride	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [PROFICIENT RX LP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GLIMEPIRIDE TABLET [PROFICIENT RX LP]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [PROFICIENT RX LP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [PROFICIENT RX LP]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [PROFICIENT RX LP]	1
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-003	GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]	9	Current NDC, Legacy NDC, 3 package rows	20231129_9b74fbac-9e04-4927-9981-1e3dace89c6d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6KY687524K	GLIMEPIRIDE	93479-97-1	GLIMEPIRIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199247	glimepiride 4 MG Oral Tablet	PSN	58c4261e-e98f-4280-9562-2800956dff14	18
199247	glimepiride 4 MG Oral Tablet	SCD	58c4261e-e98f-4280-9562-2800956dff14	18
199246	glimepiride 2 MG Oral Tablet	PSN	9e863f84-d6f2-4d61-8250-774569e84353	12
199247	glimepiride 4 MG Oral Tablet	PSN	9e863f84-d6f2-4d61-8250-774569e84353	12
199246	glimepiride 2 MG Oral Tablet	SCD	9e863f84-d6f2-4d61-8250-774569e84353	12
199247	glimepiride 4 MG Oral Tablet	SCD	9e863f84-d6f2-4d61-8250-774569e84353	12
199245	glimepiride 1 MG Oral Tablet	PSN	9b74fbac-9e04-4927-9981-1e3dace89c6d	10
199246	glimepiride 2 MG Oral Tablet	PSN	9b74fbac-9e04-4927-9981-1e3dace89c6d	10
199247	glimepiride 4 MG Oral Tablet	PSN	9b74fbac-9e04-4927-9981-1e3dace89c6d	10
199245	glimepiride 1 MG Oral Tablet	SCD	9b74fbac-9e04-4927-9981-1e3dace89c6d	10
199246	glimepiride 2 MG Oral Tablet	SCD	9b74fbac-9e04-4927-9981-1e3dace89c6d	10
199247	glimepiride 4 MG Oral Tablet	SCD	9b74fbac-9e04-4927-9981-1e3dace89c6d	10
199247	glimepiride 4 MG Oral Tablet	PSN	68cb4fcd-5bc3-4f53-9085-86df6a4246d6	6
199247	glimepiride 4 MG Oral Tablet	SCD	68cb4fcd-5bc3-4f53-9085-86df6a4246d6	6
199247	glimepiride 4 MG Oral Tablet	PSN	3e81a39a-30bb-4d6d-82e1-17d7134365be	5
199247	glimepiride 4 MG Oral Tablet	SCD	3e81a39a-30bb-4d6d-82e1-17d7134365be	5
199247	glimepiride 4 MG Oral Tablet	PSN	2b57dfa7-f2c2-45ca-e054-00144ff8d46c	3
199247	glimepiride 4 MG Oral Tablet	PSN	7cb1c5e9-40f2-5479-e053-2991aa0ae0d4	3
199247	glimepiride 4 MG Oral Tablet	PSN	4f463a8e-20ce-5674-e054-00144ff88e88	3
199247	glimepiride 4 MG Oral Tablet	SCD	7cb1c5e9-40f2-5479-e053-2991aa0ae0d4	3
199247	glimepiride 4 MG Oral Tablet	SCD	4f463a8e-20ce-5674-e054-00144ff88e88	3
199247	glimepiride 4 MG Oral Tablet	SCD	2b57dfa7-f2c2-45ca-e054-00144ff8d46c	3
199247	glimepiride 4 MG Oral Tablet	PSN	8aaa0f8d-754f-059a-e053-2995a90a0e7f	2
199247	glimepiride 4 MG Oral Tablet	SCD	8aaa0f8d-754f-059a-e053-2995a90a0e7f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-003-01	16729000301	100 TABLET in 1 BOTTLE (16729-003-01)	100 tablet	2007-08-23	0000-00-00	No	No	Current
16729-003-16	16729000316	500 TABLET in 1 BOTTLE (16729-003-16)	500 tablet	2016-08-25	0000-00-00	No	No	Current
16729-003-17	16729000317	1000 in 1 BOTTLE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glimepiride	Bryant Ranch Prepack	2026-05-19	HUMAN PRESCRIPTION DRUG LABEL	12
Glimepiride	PD-Rx Pharmaceuticals, Inc.	2026-01-07	HUMAN PRESCRIPTION DRUG LABEL	18
Glimepiride	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	5
Glimepiride	Accord Healthcare Inc \| Intas Pharmaceuticals Limited	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	10
Glimepiride	REMEDYREPACK INC.	2025-03-25	HUMAN PRESCRIPTION DRUG LABEL	10
Glimepiride	Preferred Pharmaceuticals Inc.	2024-05-10	HUMAN PRESCRIPTION DRUG LABEL	4
Glimepiride	A-S Medication Solutions	2023-02-28	HUMAN PRESCRIPTION DRUG LABEL	18
GLIMEPIRIDE	DIRECT RX	2023-01-11	HUMAN PRESCRIPTION DRUG LABEL	3
Glimepiride	St. Mary’s Medical Park Pharmacy	2022-12-22	HUMAN PRESCRIPTION DRUG LABEL	4
Glimepiride	REMEDYREPACK INC.	2022-06-09	HUMAN PRESCRIPTION DRUG LABEL	7
Glimepiride	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	6
Glimepiride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
Glimepiride	Quality Care Products, LLC	2021-04-14	HUMAN PRESCRIPTION DRUG LABEL	3
Glimepiride	NuCare Pharmaceuticals, Inc.	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	4
Glimepiride	NuCare Pharmaceuticals,Inc.	2021-02-18	HUMAN PRESCRIPTION DRUG LABEL	2
Glimepiride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-30	HUMAN PRESCRIPTION DRUG LABEL	2
Glimepiride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-09-15	HUMAN PRESCRIPTION DRUG LABEL	3
Glimepiride	Preferred Pharmaceuticals Inc.	2018-06-18	HUMAN PRESCRIPTION DRUG LABEL	4