Glimepiride

Product NDC
16571-774
11-digit product format
165710774
Labeler code
16571
Product ID
16571-774_f06a97e3-4349-4df3-87de-4479c1ed69bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA202759
Marketing category
ANDA
Marketing start
2012-06-29
Substance
GLIMEPIRIDE
Active strength
2 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A202759-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2012-06-29
A202759-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2012-06-29
A202759-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2012-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202759-001AB
A202759-002AB
A202759-003AB

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 06:07:402026-07A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202759-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202759-003GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202759-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-291e350fbaab3a…

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 06:07:402026-07A202759-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202759-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202759-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202759-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202759-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202759-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202759-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202759-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202759-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202759-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202759-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202759-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202759-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202759-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202759-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202759-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202759-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202759-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202759-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202759-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202759-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202759-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202759-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202759-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202759-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202759-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202759-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202759-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202759-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202759-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202759-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202759-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202759-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202759-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202759-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202759-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202759-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202759-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202759-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202759-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Glimepiride
Listing expiration
2027-12-31

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
48ada723-8144-497d-afd6-a8c52a1dd3ffAvailable 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
16571-774-01Glimepiride100 in 1 BOTTLETABLET1004
16571-774-50Glimepiride500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-774-01EA - Each16571-77483331726-9c6d-46e1-93f6-75eda462e84312022-03-09
16571-774-50EA - Each16571-77469e8c2ab-e3ba-4dcf-ab68-08111031bb5d12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-774GLIMEPIRIDE TABLET [RISING PHARMA HOLDINGS, INC.]3Current NDC, Legacy NDC, 2 package rows20231101_48ada723-8144-497d-afd6-a8c52a1dd3ff.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDESt. Mary's Medical Park Pharmacyfc9d8495-184c-3af1-e053-6394a90a5e292026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEPreferred Pharmaceuticals Inc.744a5cca-7863-491a-b43a-1b649791702c2026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEBryant Ranch Prepack248c3cb3-4501-4b85-bd1d-0624b6afda2c2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEBryant Ranch Prepack90d675cb-6def-49a3-b8b4-229f19d6b6172026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEAurobindo Pharma Limited28eefc95-d92e-4555-b6c5-2933860b06102026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.1450f455-a14a-4f9b-b3aa-dae49ea0c1862026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEProficient Rx LPdbed06f9-7758-4c96-9af0-1ed6103db7df2026-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEProficient Rx LPe12ab052-e3d6-4246-b727-f1e3f9057f092026-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDERising Pharma Holdings, Inc.48ada723-8144-497d-afd6-a8c52a1dd3ff2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
ndc (product): 16571-774
GlimepirideGLIMEPIRIDEA-S Medication Solutionsb6ce0eea-149d-4aed-a615-0b1c8f3f6a8e2025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDENorthwind Health Company, LLC10a36c79-1b24-46b7-e063-6294a90a8dca2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEA-S Medication Solutions489dc098-0ac7-4f8e-b258-326229539c7c2025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEA-S Medication Solutionsbe7175ae-ba53-45b8-9554-e4f4ebf568832025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEDirect_Rxfd26934e-daea-f47b-e053-6394a90a4bc62025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEA-S Medication Solutionsa11680ba-2750-43ab-a1b1-a52ebe3e139f2023-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEA-S Medication Solutionse8da2484-43a7-4dcb-84d5-d84596feb9f62023-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759
GlimepirideGLIMEPIRIDEProficient Rx LP8f687fa6-54eb-4556-8ea6-aafec49a87d12023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202759
application number: ANDA202759

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSN1450f455-a14a-4f9b-b3aa-dae49ea0c1866
199246glimepiride 2 MG Oral TabletSCD1450f455-a14a-4f9b-b3aa-dae49ea0c1866
199245glimepiride 1 MG Oral TabletPSN48ada723-8144-497d-afd6-a8c52a1dd3ff4
199246glimepiride 2 MG Oral TabletPSNfd26934e-daea-f47b-e053-6394a90a4bc64
199246glimepiride 2 MG Oral TabletPSNbe7175ae-ba53-45b8-9554-e4f4ebf568834
199246glimepiride 2 MG Oral TabletPSN48ada723-8144-497d-afd6-a8c52a1dd3ff4
199247glimepiride 4 MG Oral TabletPSN48ada723-8144-497d-afd6-a8c52a1dd3ff4
199245glimepiride 1 MG Oral TabletSCD48ada723-8144-497d-afd6-a8c52a1dd3ff4
199246glimepiride 2 MG Oral TabletSCD48ada723-8144-497d-afd6-a8c52a1dd3ff4
199246glimepiride 2 MG Oral TabletSCDfd26934e-daea-f47b-e053-6394a90a4bc64
199246glimepiride 2 MG Oral TabletSCDbe7175ae-ba53-45b8-9554-e4f4ebf568834
199247glimepiride 4 MG Oral TabletSCD48ada723-8144-497d-afd6-a8c52a1dd3ff4
199246glimepiride 2 MG Oral TabletPSN489dc098-0ac7-4f8e-b258-326229539c7c3
199246glimepiride 2 MG Oral TabletSCD489dc098-0ac7-4f8e-b258-326229539c7c3
199246glimepiride 2 MG Oral TabletPSNdbed06f9-7758-4c96-9af0-1ed6103db7df2
199246glimepiride 2 MG Oral TabletPSN10a36c79-1b24-46b7-e063-6294a90a8dca2
199246glimepiride 2 MG Oral TabletSCD10a36c79-1b24-46b7-e063-6294a90a8dca2
199246glimepiride 2 MG Oral TabletSCDdbed06f9-7758-4c96-9af0-1ed6103db7df2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-774-0116571077401100 TABLET in 1 BOTTLE (16571-774-01) 100 tablet2012-06-290000-00-00NoNoCurrent
16571-774-5016571077450500 TABLET in 1 BOTTLE (16571-774-50) 500 tablet2012-06-290000-00-00NoNoCurrent