Glimepiride

Product NDC
61442-116
11-digit product format
614420116
Labeler code
61442
Product ID
61442-116_2386d706-9dab-4ae0-e063-6394a90a8a06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA077911
Marketing category
ANDA
Marketing start
2012-01-01
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077911-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2009-09-22
A077911-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2009-09-22
A077911-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2009-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077911-001AB
A077911-002AB
A077911-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-22caaa826d4ba7…
2026-08-18 06:07:402026-07A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-22caaa826d4ba7…
2026-08-18 06:07:402026-07A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077911-002GLIMEPIRIDE2MGTABLET / ORALAB2009-09-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077911-003GLIMEPIRIDE4MGTABLET / ORALAB2009-09-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077911-001GLIMEPIRIDE1MGTABLET / ORALAB2009-09-221e350fbaab3a…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077911-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077911-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077911-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077911-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077911-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077911-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077911-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077911-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077911-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077911-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077911-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077911-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077911-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077911-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077911-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077911-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077911-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077911-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077911-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077911-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077911-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077911-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077911-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077911-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077911-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077911-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077911-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077911-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077911-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077911-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077911-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077911-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077911-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077911-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077911-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077911-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077911-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077911-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077911-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077911-001AB11e350fbaab3a…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIMEPIRIDE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6KY687524KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199245Internal RxNorm lookup
199246Internal RxNorm lookup
199247Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
72d88c6d-2f0a-4bf8-aa7f-1e1811794187Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b890b964-2cf0-4439-aaf3-900c9e3e9e49Product name120160602
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
d36d861f-8a90-80cc-8935-1e6be9b4c7ebProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61442-116-01Glimepiride100 in 1 BOTTLETABLET10011
61442-116-05Glimepiride500 in 1 BOTTLETABLET50011
61442-116-10Glimepiride1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-116-01EA - Each61442-116dea3704e-f1cb-4652-8408-29176dbc0a2d12012-07-24
61442-116-05EA - Each61442-11609b98cc6-beb7-4ce3-8418-dc5d0c65aa8a12016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]7
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]7
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGGLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]7
POVIDONE K30INACTIVE INGREDIENTU725QWY32XGLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]7
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-116GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.]11Current NDC, Legacy NDC, 3 package rows20241004_72d88c6d-2f0a-4bf8-aa7f-1e1811794187.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.647a146c-c752-4589-8619-aed5c720ca542026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.ed7a3a8e-97dd-4a5a-9497-001acfd2f1f02026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.f4ffb19e-6d65-49fd-83ce-514d38d9d97c2025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.11ae3189-6139-4470-95d5-72abc0f5b0d02025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.2794f86b-d521-414b-8154-5dd1e25196532025-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
GlimepirideGLIMEPIRIDEGolden State Medical Supply, Inc.4f83e203-c102-47fa-bb8e-4fc5541e0d6f2024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
GlimepirideGLIMEPIRIDECarlsbad Technology, Inc.72d88c6d-2f0a-4bf8-aa7f-1e18117941872024-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911
ndc (product): 61442-116
GlimepirideGLIMEPIRIDEAphena Pharma Solutions - Tennessee, LLC00b9e312-921e-41e6-ad27-0a6ce87f82982019-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077911
application number: ANDA077911

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSN11ae3189-6139-4470-95d5-72abc0f5b0d022
199246glimepiride 2 MG Oral TabletSCD11ae3189-6139-4470-95d5-72abc0f5b0d022
199246glimepiride 2 MG Oral TabletPSN2794f86b-d521-414b-8154-5dd1e251965316
199246glimepiride 2 MG Oral TabletSCD2794f86b-d521-414b-8154-5dd1e251965316
199245glimepiride 1 MG Oral TabletPSN72d88c6d-2f0a-4bf8-aa7f-1e181179418711
199246glimepiride 2 MG Oral TabletPSN72d88c6d-2f0a-4bf8-aa7f-1e181179418711
199247glimepiride 4 MG Oral TabletPSN72d88c6d-2f0a-4bf8-aa7f-1e181179418711
199245glimepiride 1 MG Oral TabletSCD72d88c6d-2f0a-4bf8-aa7f-1e181179418711
199246glimepiride 2 MG Oral TabletSCD72d88c6d-2f0a-4bf8-aa7f-1e181179418711
199247glimepiride 4 MG Oral TabletSCD72d88c6d-2f0a-4bf8-aa7f-1e181179418711
199245glimepiride 1 MG Oral TabletPSN4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199246glimepiride 2 MG Oral TabletPSN4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199247glimepiride 4 MG Oral TabletPSN4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199245glimepiride 1 MG Oral TabletSCD4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199246glimepiride 2 MG Oral TabletSCD4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199247glimepiride 4 MG Oral TabletSCD4f83e203-c102-47fa-bb8e-4fc5541e0d6f6
199246glimepiride 2 MG Oral TabletPSN8b309577-5461-43eb-bb0b-0a5293ee93922
199246glimepiride 2 MG Oral TabletPSN5659e616-4858-4543-8e0b-c5477519f8fe2
199246glimepiride 2 MG Oral TabletSCD8b309577-5461-43eb-bb0b-0a5293ee93922
199246glimepiride 2 MG Oral TabletSCD5659e616-4858-4543-8e0b-c5477519f8fe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61442-116-0161442011601100 TABLET in 1 BOTTLE (61442-116-01) 100 tablet2012-01-010000-00-00NoNoCurrent
61442-116-0561442011605500 TABLET in 1 BOTTLE (61442-116-05) 500 tablet2012-01-010000-00-00NoNoCurrent
61442-116-10614420116101000 TABLET in 1 BOTTLE (61442-116-10) 1000 tablet2012-01-010000-00-00NoNoCurrent