Glimepiride

Product NDC: 16729-002
Requested package NDC: 16729-002-01
11-digit product format: 167290002
Labeler code: 16729
Product ID: 16729-002_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: 2 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.

Product history page 1 of 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB	2007-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB	2007-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078181-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	2007-08-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078181-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078181-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078181-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078181-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078181-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078181-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078181-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078181-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078181-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078181-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078181-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078181-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078181-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078181-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078181-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078181-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078181-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078181-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078181-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078181-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLIMEPIRIDE	2 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
16729-002-01	Glimepiride	100 in 1 BOTTLE	TABLET	100	10
16729-002-16	Glimepiride	500 in 1 BOTTLE	TABLET	500	10
16729-002-17	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
16729-002-01	EA - Each	16729-002	08a03fc2-8f33-47f5-b9d8-86517569fcf2	1	2012-07-24
16729-002-16	EA - Each	16729-002	e1715c83-c25a-4200-90ec-893cd01df508	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.]	7
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	7
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	7
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 [DIRECTRX]	1
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [DIRECTRX]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	GLIMEPIRIDE TABLET [DIRECTRX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GLIMEPIRIDE TABLET [DIRECTRX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [DIRECTRX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [DIRECTRX]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [DIRECTRX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [DIRECTRX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-002	GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]	9	Current NDC, Legacy NDC, 3 package rows	20231129_9b74fbac-9e04-4927-9981-1e3dace89c6d.zip

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 · 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 (package): 16729-002-01 ndc (product): 16729-002 ndc11 (package): 16729000201
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

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
199246	glimepiride 2 MG Oral Tablet	PSN	1b3c7d74-f80b-4fb1-8dca-66880af5d3fc	21
199246	glimepiride 2 MG Oral Tablet	SCD	1b3c7d74-f80b-4fb1-8dca-66880af5d3fc	21
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
199246	glimepiride 2 MG Oral Tablet	PSN	f2f2d6da-eb40-4290-e053-2a95a90a6ca0	4
199246	glimepiride 2 MG Oral Tablet	PSN	beb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b	4
199246	glimepiride 2 MG Oral Tablet	SCD	f2f2d6da-eb40-4290-e053-2a95a90a6ca0	4
199246	glimepiride 2 MG Oral Tablet	SCD	beb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b	4
199246	glimepiride 2 MG Oral Tablet	PSN	77e5e09e-4117-3136-e053-2991aa0a9379	3
199246	glimepiride 2 MG Oral Tablet	PSN	525698da-7eb4-6fbd-e054-00144ff8d46c	3
199246	glimepiride 2 MG Oral Tablet	SCD	77e5e09e-4117-3136-e053-2991aa0a9379	3
199246	glimepiride 2 MG Oral Tablet	SCD	525698da-7eb4-6fbd-e054-00144ff8d46c	3
199246	glimepiride 2 MG Oral Tablet	PSN	8f9cce0a-1054-3c21-e053-2a95a90a8b87	2
199246	glimepiride 2 MG Oral Tablet	PSN	87c49630-a574-4992-e053-2a95a90aa32d	2
199246	glimepiride 2 MG Oral Tablet	SCD	8f9cce0a-1054-3c21-e053-2a95a90a8b87	2
199246	glimepiride 2 MG Oral Tablet	SCD	87c49630-a574-4992-e053-2a95a90aa32d	2
199246	glimepiride 2 MG Oral Tablet	PSN	254e279f-c852-1197-e054-00144ff8d46c	1
199246	glimepiride 2 MG Oral Tablet	PSN	feeb6508-bad3-428d-8a76-ddc55793b109	1
199246	glimepiride 2 MG Oral Tablet	SCD	254e279f-c852-1197-e054-00144ff8d46c	1
199246	glimepiride 2 MG Oral Tablet	SCD	feeb6508-bad3-428d-8a76-ddc55793b109	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-002-01	16729000201	100 TABLET in 1 BOTTLE (16729-002-01)	100 tablet	2007-08-23	0000-00-00	No	No	Current

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	21
Glimepiride	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Glimepiride	Accord Healthcare Inc \| Intas Pharmaceuticals Limited	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	10
Glimepiride	REMEDYREPACK INC.	2024-07-30	HUMAN PRESCRIPTION DRUG LABEL	12
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	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	4
Glimepiride	NuCare Pharmaceuticals,Inc.	2022-08-16	HUMAN PRESCRIPTION DRUG LABEL	3
GLIMEPIRIDE	Dircet_Rx	2022-01-21	HUMAN PRESCRIPTION DRUG LABEL	3
Glimepiride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
Glimepiride	NuCare Pharmaceuticals, Inc.	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	6
Glimepiride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-14	HUMAN PRESCRIPTION DRUG LABEL	3
Glimepiride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-31	HUMAN PRESCRIPTION DRUG LABEL	2
Glimepiride	Preferred Pharmaceuticals Inc.	2020-06-04	HUMAN PRESCRIPTION DRUG LABEL	5
GLIMEPIRIDE	Direct_Rx	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
Glimepiride	Aidarex Pharmaceuticals LLC	2016-12-01	HUMAN PRESCRIPTION DRUG LABEL	1
GLIMEPIRIDE	DirectRX	2015-11-24	HUMAN PRESCRIPTION DRUG LABEL	1