Glimepiride

Product NDC: 55111-322
11-digit product format: 551110322
Labeler code: 55111
Product ID: 55111-322_e3d50334-9896-b2f9-a481-8383eb84b16a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glimepiride
Dosage form: TABLET
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA077091
Marketing category: ANDA
Marketing start: 2005-10-06
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	RLD / RS	Approval date
A077091-001	GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	RS	2005-10-06
A077091-002	GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06
A077091-003	GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077091-001	AB
A077091-002	AB
A077091-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	RS	2005-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	RS	2005-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	RS	2005-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB	RS	2005-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077091-002	GLIMEPIRIDE	2MG	TABLET / ORAL	AB		2005-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077091-003	GLIMEPIRIDE	4MG	TABLET / ORAL	AB		2005-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077091-001	GLIMEPIRIDE	1MG	TABLET / ORAL	AB		2005-10-06	`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	A077091-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077091-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077091-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077091-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077091-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077091-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077091-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077091-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077091-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077091-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077091-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077091-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077091-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077091-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077091-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077091-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077091-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077091-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077091-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077091-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077091-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077091-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077091-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077091-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077091-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077091-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077091-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077091-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077091-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077091-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077091-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077091-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077091-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077091-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077091-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077091-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077091-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077091-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077091-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077091-001	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	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
07ad4366-4b21-f633-49f3-c2b35f88168d	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
55111-322-01	Glimepiride	100 in 1 BOTTLE	TABLET	100	12
55111-322-05	Glimepiride	500 in 1 BOTTLE	TABLET	500	12
55111-322-30	Glimepiride	30 in 1 BOTTLE	TABLET	30	12
55111-322-78	Glimepiride	100 in 1 CARTON	TABLET	100	12
55111-322-79	Glimepiride	1 in 1 BLISTER PACK	TABLET	1	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-322-01	EA - Each	55111-322	ff011dae-3a9e-463d-b01d-b66d868e65f2	1	2012-07-24
55111-322-05	EA - Each	55111-322	1c4b593e-e8e8-4de9-be4d-287b26013790	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIMEPIRIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLIMEPIRIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLIMEPIRIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GLIMEPIRIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
Povidone	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	7
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]	3
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]	3
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]	3
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]	3
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]	3
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]	3
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]	3
povidone	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]	3
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]	2
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]	2
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [STAT RX USA LLC]	2
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]	2
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]	2
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [STAT RX USA LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIMEPIRIDE TABLET [STAT RX USA LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLIMEPIRIDE TABLET [STAT RX USA LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLIMEPIRIDE TABLET [STAT RX USA LLC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [STAT RX USA LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [STAT RX USA LLC]	2
povidone	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [STAT RX USA LLC]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	GLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [STAT RX USA LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
GLIMEPIRIDE	ACTIVE INGREDIENT	6KY687524K	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
GLIMEPIRIDE	ACTIVE MOIETY	6KY687524K	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-322	GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	12	Current NDC, Legacy NDC, 5 package rows	20190130_07ad4366-4b21-f633-49f3-c2b35f88168d.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glimepiride	GLIMEPIRIDE	Cardinal Health 107, LLC	cc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	NuCare Pharmaceuticals,Inc.	bf8e5993-5ee7-d26d-e053-2a95a90ae5df	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	AvPAK	93f1e064-fcbd-e8fd-e053-2995a90a5dbb	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	f3184cd3-df99-db32-e053-2995a90aa573	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	Northwind Health Company, LLC	dae404ac-881a-14d8-e053-2995a90acd41	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	101cdc41-2131-4425-b550-6a0a60b5f4a4	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	PD-Rx Pharmaceuticals, Inc.	657f1b51-2f82-44f6-a23d-97f4b34b3c45	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	American Health Packaging	0003458f-352a-46fa-9d99-230daa76ae29	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	Proficient Rx LP	1f102e4c-1954-4f17-8c60-4dad79f25a25	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	NuCare Pharmaceuticals,Inc.	abc187f1-8645-23e9-e053-2a95a90a64a7	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	be772fca-1579-4fba-a4b7-04b970d09e45	2023-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	0a1eaf23-d5fd-4b3e-96c5-68ff16f0033b	2023-12-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	a9461830-1c4f-4bc4-b622-1c44112a76b9	2023-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	A-S Medication Solutions	def20e38-01f7-4ead-beb6-3dc11062a342	2023-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	Bryant Ranch Prepack	ebb9f080-b11d-5d18-36f0-627107e7fbcd	2020-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091
Glimepiride	GLIMEPIRIDE	Dr. Reddy's Laboratories Limited	07ad4366-4b21-f633-49f3-c2b35f88168d	2019-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077091 application number: ANDA077091 ndc (product): 55111-322

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	101cdc41-2131-4425-b550-6a0a60b5f4a4	18
199247	glimepiride 4 MG Oral Tablet	SCD	101cdc41-2131-4425-b550-6a0a60b5f4a4	18
199245	glimepiride 1 MG Oral Tablet	PSN	07ad4366-4b21-f633-49f3-c2b35f88168d	12
199246	glimepiride 2 MG Oral Tablet	PSN	07ad4366-4b21-f633-49f3-c2b35f88168d	12
199247	glimepiride 4 MG Oral Tablet	PSN	07ad4366-4b21-f633-49f3-c2b35f88168d	12
199245	glimepiride 1 MG Oral Tablet	SCD	07ad4366-4b21-f633-49f3-c2b35f88168d	12
199246	glimepiride 2 MG Oral Tablet	SCD	07ad4366-4b21-f633-49f3-c2b35f88168d	12
199247	glimepiride 4 MG Oral Tablet	SCD	07ad4366-4b21-f633-49f3-c2b35f88168d	12
199245	glimepiride 1 MG Oral Tablet	PSN	0003458f-352a-46fa-9d99-230daa76ae29	11
199246	glimepiride 2 MG Oral Tablet	PSN	0003458f-352a-46fa-9d99-230daa76ae29	11
199247	glimepiride 4 MG Oral Tablet	PSN	0003458f-352a-46fa-9d99-230daa76ae29	11
199245	glimepiride 1 MG Oral Tablet	SCD	0003458f-352a-46fa-9d99-230daa76ae29	11
199246	glimepiride 2 MG Oral Tablet	SCD	0003458f-352a-46fa-9d99-230daa76ae29	11
199247	glimepiride 4 MG Oral Tablet	SCD	0003458f-352a-46fa-9d99-230daa76ae29	11
199245	glimepiride 1 MG Oral Tablet	PSN	93f1e064-fcbd-e8fd-e053-2995a90a5dbb	5
199246	glimepiride 2 MG Oral Tablet	PSN	93f1e064-fcbd-e8fd-e053-2995a90a5dbb	5
199247	glimepiride 4 MG Oral Tablet	PSN	93f1e064-fcbd-e8fd-e053-2995a90a5dbb	5
199245	glimepiride 1 MG Oral Tablet	SCD	93f1e064-fcbd-e8fd-e053-2995a90a5dbb	5
199246	glimepiride 2 MG Oral Tablet	SCD	93f1e064-fcbd-e8fd-e053-2995a90a5dbb	5
199247	glimepiride 4 MG Oral Tablet	SCD	93f1e064-fcbd-e8fd-e053-2995a90a5dbb	5
199247	glimepiride 4 MG Oral Tablet	PSN	def20e38-01f7-4ead-beb6-3dc11062a342	3
199247	glimepiride 4 MG Oral Tablet	PSN	abc187f1-8645-23e9-e053-2a95a90a64a7	3
199247	glimepiride 4 MG Oral Tablet	SCD	def20e38-01f7-4ead-beb6-3dc11062a342	3
199247	glimepiride 4 MG Oral Tablet	SCD	abc187f1-8645-23e9-e053-2a95a90a64a7	3
199245	glimepiride 1 MG Oral Tablet	PSN	3b20ae5e-9807-46c2-9de1-b64e76e61730	2
199246	glimepiride 2 MG Oral Tablet	PSN	e2ed9eeb-e67d-485f-86cb-eb9061bd9d96	2
199246	glimepiride 2 MG Oral Tablet	PSN	3b20ae5e-9807-46c2-9de1-b64e76e61730	2
199247	glimepiride 4 MG Oral Tablet	PSN	f3184cd3-df99-db32-e053-2995a90aa573	2
199247	glimepiride 4 MG Oral Tablet	PSN	e2ed9eeb-e67d-485f-86cb-eb9061bd9d96	2
199247	glimepiride 4 MG Oral Tablet	PSN	5a10ec35-1616-4014-8f1c-4344e87007dc	2
199247	glimepiride 4 MG Oral Tablet	PSN	3b20ae5e-9807-46c2-9de1-b64e76e61730	2
199245	glimepiride 1 MG Oral Tablet	SCD	3b20ae5e-9807-46c2-9de1-b64e76e61730	2
199246	glimepiride 2 MG Oral Tablet	SCD	3b20ae5e-9807-46c2-9de1-b64e76e61730	2
199246	glimepiride 2 MG Oral Tablet	SCD	e2ed9eeb-e67d-485f-86cb-eb9061bd9d96	2
199247	glimepiride 4 MG Oral Tablet	SCD	5a10ec35-1616-4014-8f1c-4344e87007dc	2
199247	glimepiride 4 MG Oral Tablet	SCD	e2ed9eeb-e67d-485f-86cb-eb9061bd9d96	2
199247	glimepiride 4 MG Oral Tablet	SCD	3b20ae5e-9807-46c2-9de1-b64e76e61730	2
199247	glimepiride 4 MG Oral Tablet	SCD	f3184cd3-df99-db32-e053-2995a90aa573	2
199247	glimepiride 4 MG Oral Tablet	PSN	a9461830-1c4f-4bc4-b622-1c44112a76b9	1
199247	glimepiride 4 MG Oral Tablet	PSN	9275a6af-b7f2-4d1a-b412-14a3c611e6f8	1
199247	glimepiride 4 MG Oral Tablet	SCD	9275a6af-b7f2-4d1a-b412-14a3c611e6f8	1
199247	glimepiride 4 MG Oral Tablet	SCD	a9461830-1c4f-4bc4-b622-1c44112a76b9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-322-01	55111032201	100 TABLET in 1 BOTTLE (55111-322-01)	100 tablet	2005-10-06	0000-00-00	No	No	Current
55111-322-05	55111032205	500 TABLET in 1 BOTTLE (55111-322-05)	500 tablet	2005-10-06	0000-00-00	No	No	Current
55111-322-30	55111032230	30 TABLET in 1 BOTTLE (55111-322-30)	30 tablet	2005-10-06	0000-00-00	No	No	Current
55111-322-78	55111032278	100 BLISTER PACK in 1 CARTON (55111-322-78) / 1 TABLET in 1 BLISTER PACK (55111-322-79)	100 blister pack	2005-10-06	0000-00-00	No	No	Current
55111-322-79	55111032279	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glimepiride	AvPAK	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	5
Glimepiride	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
Glimepiride	PD-Rx Pharmaceuticals, Inc.	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	18
Glimepiride	Legacy Pharmaceutical Packaging, LLC	2025-03-17	HUMAN PRESCRIPTION DRUG LABEL	7
Glimepiride	American Health Packaging	2024-11-13	HUMAN PRESCRIPTION DRUG LABEL	11
Glimepiride	REMEDYREPACK INC.	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL	3
Glimepiride	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	3
Glimepiride	A-S Medication Solutions	2023-12-03	HUMAN PRESCRIPTION DRUG LABEL	1
Glimepiride	A-S Medication Solutions	2023-06-22	HUMAN PRESCRIPTION DRUG LABEL	3
Glimepiride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2023-01-06	HUMAN PRESCRIPTION DRUG LABEL	2
Glimepiride	Preferred Pharmaceuticals, Inc.	2022-06-20	HUMAN PRESCRIPTION DRUG LABEL	3
Glimepiride	Bryant Ranch Prepack	2021-11-22	HUMAN PRESCRIPTION DRUG LABEL	10
GLIMEPIRIDE	St Marys Medical Park Pharmacy	2020-04-01	HUMAN PRESCRIPTION DRUG LABEL	6
Glimepiride	Dr. Reddy's Laboratories Limited \| Dr. Reddy's Laboratories Limited (FTO-III) \| DR. REDDY'S LABORATORIES LIMITED (FTO-Sez-Process Unit-01)	2019-01-16	HUMAN PRESCRIPTION DRUG LABEL	12
Glimepiride	Blenheim Pharmacal, Inc.	2015-03-04	HUMAN PRESCRIPTION DRUG LABEL	2
Glimepiride	Aidarex Pharmaceuticals LLC	2014-01-03	HUMAN PRESCRIPTION DRUG LABEL	1
Glimepiride	NCS HealthCare of KY, Inc dba Vangard Labs	2013-08-26	HUMAN PRESCRIPTION DRUG LABEL	10
GLIMEPIRIDE - STAT Rx USA LLC \| PSS World Medical Inc.	STAT Rx USA LLC \| PSS World Medical Inc.	2012-03-27	HUMAN PRESCRIPTION DRUG LABEL	2
Glimepiride Tablets USP	Rebel Distributors Corp	2010-09-28	HUMAN PRESCRIPTION DRUG LABEL	2