Glimepiride

Product NDC
43063-122
11-digit product format
430630122
Labeler code
43063
Product ID
43063-122_41372f7a-4296-6e3d-e063-6394a90af659
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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-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
GLIMEPIRIDE4 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
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
101cdc41-2131-4425-b550-6a0a60b5f4a4Available 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
43063-122-30Glimepiride30 in 1 BOTTLE, PLASTICTABLET3018
43063-122-90Glimepiride90 in 1 BOTTLE, PLASTICTABLET9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-122-30EA - Each43063-12243d2bacb-7958-4e5b-aefb-21a04ea49eec12012-07-24
43063-122-90EA - Each43063-12279baee10-e21e-4121-a03d-04ba0899cf8712012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-122GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]17Current NDC, 2 package rows20241222_101cdc41-2131-4425-b550-6a0a60b5f4a4.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
ndc (product): 43063-122
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
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
199247glimepiride 4 MG Oral TabletPSN101cdc41-2131-4425-b550-6a0a60b5f4a418
199247glimepiride 4 MG Oral TabletSCD101cdc41-2131-4425-b550-6a0a60b5f4a418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43063-122-304306301223030 TABLET in 1 BOTTLE, PLASTIC (43063-122-30) 30 tablet2024-12-19NoNoCurrent
43063-122-904306301229090 TABLET in 1 BOTTLE, PLASTIC (43063-122-90) 90 tablet2009-12-23NoNoCurrent