Glimepiride

Product NDC
63629-3043
11-digit product format
636293043
Labeler code
63629
Product ID
63629-3043_d877f389-167f-42c4-a9c2-adc90a7cad20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077091
Marketing category
ANDA
Marketing start
2005-10-06
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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ebb9f080-b11d-5d18-36f0-627107e7fbcdAvailable 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
63629-3043-1Glimepiride30 in 1 BOTTLETABLET308
63629-3043-2Glimepiride60 in 1 BOTTLETABLET608
63629-3043-3Glimepiride90 in 1 BOTTLETABLET908
63629-3043-4Glimepiride100 in 1 BOTTLETABLET1008
63629-3043-5Glimepiride180 in 1 BOTTLETABLET1808

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3043-1EA - Each63629-3043744a3d19-6a05-4d31-be3f-5ab0bc447ee112012-07-24
63629-3043-2EA - Each63629-3043c2fa4a4d-1a91-49cf-81b3-842fc0c83cb812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3043GLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 5 package rows20200828_ebb9f080-b11d-5d18-36f0-627107e7fbcd.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
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
ndc (product): 63629-3043
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
199246glimepiride 2 MG Oral TabletPSNebb9f080-b11d-5d18-36f0-627107e7fbcd8
199246glimepiride 2 MG Oral TabletSCDebb9f080-b11d-5d18-36f0-627107e7fbcd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3043-16362930430130 TABLET in 1 BOTTLE (63629-3043-1) 30 tablet2010-06-230000-00-00NoNoCurrent
63629-3043-26362930430260 TABLET in 1 BOTTLE (63629-3043-2) 60 tablet2010-06-230000-00-00NoNoCurrent
63629-3043-36362930430390 TABLET in 1 BOTTLE (63629-3043-3) 90 tablet2007-06-070000-00-00NoNoCurrent
63629-3043-463629304304100 TABLET in 1 BOTTLE (63629-3043-4) 100 tablet2007-06-070000-00-00NoNoCurrent
63629-3043-563629304305180 TABLET in 1 BOTTLE (63629-3043-5) 180 tablet2010-06-230000-00-00NoNoCurrent