Glimepiride

Product NDC
68084-326
Requested package NDC
68084-326-01
11-digit product format
680840326
Labeler code
68084
Product ID
68084-326_26cca05b-82f8-e191-e063-6394a90a56bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077091
Marketing category
ANDA
Marketing start
2009-04-22
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077091-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALABRS2005-10-06
A077091-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2005-10-06
A077091-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2005-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077091-001AB
A077091-002AB
A077091-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077091-001GLIMEPIRIDE1MGTABLET / ORALABRS2005-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077091-002GLIMEPIRIDE2MGTABLET / ORALAB2005-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077091-003GLIMEPIRIDE4MGTABLET / ORALAB2005-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077091-001GLIMEPIRIDE1MGTABLET / ORALABRS2005-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077091-002GLIMEPIRIDE2MGTABLET / ORALAB2005-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077091-003GLIMEPIRIDE4MGTABLET / ORALAB2005-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077091-001GLIMEPIRIDE1MGTABLET / ORALABRS2005-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077091-002GLIMEPIRIDE2MGTABLET / ORALAB2005-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077091-003GLIMEPIRIDE4MGTABLET / ORALAB2005-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077091-001GLIMEPIRIDE1MGTABLET / ORALABRS2005-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077091-002GLIMEPIRIDE2MGTABLET / ORALAB2005-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077091-003GLIMEPIRIDE4MGTABLET / ORALAB2005-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077091-001GLIMEPIRIDE1MGTABLET / ORALAB2005-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077091-002GLIMEPIRIDE2MGTABLET / ORALAB2005-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077091-003GLIMEPIRIDE4MGTABLET / ORALAB2005-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077091-001GLIMEPIRIDE1MGTABLET / ORALAB2005-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077091-002GLIMEPIRIDE2MGTABLET / ORALAB2005-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077091-003GLIMEPIRIDE4MGTABLET / ORALAB2005-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077091-001GLIMEPIRIDE1MGTABLET / ORALAB2005-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077091-002GLIMEPIRIDE2MGTABLET / ORALAB2005-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077091-003GLIMEPIRIDE4MGTABLET / ORALAB2005-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077091-001GLIMEPIRIDE1MGTABLET / ORALAB2005-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077091-002GLIMEPIRIDE2MGTABLET / ORALAB2005-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077091-003GLIMEPIRIDE4MGTABLET / ORALAB2005-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077091-001GLIMEPIRIDE1MGTABLET / ORALAB2005-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077091-002GLIMEPIRIDE2MGTABLET / ORALAB2005-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077091-003GLIMEPIRIDE4MGTABLET / ORALAB2005-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077091-001GLIMEPIRIDE1MGTABLET / ORALAB2005-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077091-002GLIMEPIRIDE2MGTABLET / ORALAB2005-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077091-003GLIMEPIRIDE4MGTABLET / ORALAB2005-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077091-001GLIMEPIRIDE1MGTABLET / ORALAB2005-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077091-002GLIMEPIRIDE2MGTABLET / ORALAB2005-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077091-003GLIMEPIRIDE4MGTABLET / ORALAB2005-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077091-001GLIMEPIRIDE1MGTABLET / ORALAB2005-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077091-002GLIMEPIRIDE2MGTABLET / ORALAB2005-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077091-003GLIMEPIRIDE4MGTABLET / ORALAB2005-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077091-001GLIMEPIRIDE1MGTABLET / ORALAB2005-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077091-002GLIMEPIRIDE2MGTABLET / ORALAB2005-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077091-003GLIMEPIRIDE4MGTABLET / ORALAB2005-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077091-001GLIMEPIRIDE1MGTABLET / ORALAB2005-10-068072bd15b7f6…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077091-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077091-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077091-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077091-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077091-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077091-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077091-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077091-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077091-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077091-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077091-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077091-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077091-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077091-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077091-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077091-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077091-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077091-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077091-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077091-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077091-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077091-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077091-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077091-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077091-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077091-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077091-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077091-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077091-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077091-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077091-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077091-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077091-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077091-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077091-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077091-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077091-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077091-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077091-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077091-001AB18072bd15b7f6…

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
0003458f-352a-46fa-9d99-230daa76ae29Available 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
68084-326-01Glimepiride100 in 1 BOX, UNIT-DOSETABLET10011
68084-326-11Glimepiride1 in 1 BLISTER PACKTABLET111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-326-01EA - Each68084-326f61a2576-df26-4973-a414-2d93c5a55c5a12012-07-24
68084-326-11EA - Each68084-326a5a8135f-a711-4fe8-99e4-435519d2a0c912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
ferric oxide redINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-326GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20241122_0003458f-352a-46fa-9d99-230daa76ae29.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDECardinal Health 107, LLCcc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa2026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDENuCare Pharmaceuticals,Inc.bf8e5993-5ee7-d26d-e053-2a95a90ae5df2026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEAvPAK93f1e064-fcbd-e8fd-e053-2995a90a5dbb2026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDENorthwind Health Company, LLCf3184cd3-df99-db32-e053-2995a90aa5732026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDENorthwind Health Company, LLCdae404ac-881a-14d8-e053-2995a90acd412026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.101cdc41-2131-4425-b550-6a0a60b5f4a42025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.657f1b51-2f82-44f6-a23d-97f4b34b3c452025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEAmerican Health Packaging0003458f-352a-46fa-9d99-230daa76ae292024-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
ndc (package): 68084-326-01
ndc (product): 68084-326
ndc11 (package): 68084032601
GlimepirideGLIMEPIRIDEProficient Rx LP1f102e4c-1954-4f17-8c60-4dad79f25a252024-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDENuCare Pharmaceuticals,Inc.abc187f1-8645-23e9-e053-2a95a90a64a72024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEA-S Medication Solutionsbe772fca-1579-4fba-a4b7-04b970d09e452023-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEA-S Medication Solutions0a1eaf23-d5fd-4b3e-96c5-68ff16f0033b2023-12-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEA-S Medication Solutionsa9461830-1c4f-4bc4-b622-1c44112a76b92023-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEA-S Medication Solutionsdef20e38-01f7-4ead-beb6-3dc11062a3422023-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEBryant Ranch Prepackebb9f080-b11d-5d18-36f0-627107e7fbcd2020-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091
GlimepirideGLIMEPIRIDEDr. Reddy's Laboratories Limited07ad4366-4b21-f633-49f3-c2b35f88168d2019-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077091
application number: ANDA077091

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN0003458f-352a-46fa-9d99-230daa76ae2911
199246glimepiride 2 MG Oral TabletPSN0003458f-352a-46fa-9d99-230daa76ae2911
199247glimepiride 4 MG Oral TabletPSN0003458f-352a-46fa-9d99-230daa76ae2911
199245glimepiride 1 MG Oral TabletSCD0003458f-352a-46fa-9d99-230daa76ae2911
199246glimepiride 2 MG Oral TabletSCD0003458f-352a-46fa-9d99-230daa76ae2911
199247glimepiride 4 MG Oral TabletSCD0003458f-352a-46fa-9d99-230daa76ae2911
199246glimepiride 2 MG Oral TabletPSNcc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa8
199246glimepiride 2 MG Oral TabletSCDcc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-326-0168084032601100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-326-01) / 1 TABLET in 1 BLISTER PACK (68084-326-11) 100 blister pack2009-04-220000-00-00NoNoCurrent