Glimepiride

Product NDC
71921-214
11-digit product format
719210214
Labeler code
71921
Product ID
71921-214_52fcdeaf-e64f-48bd-b90d-e7502b104ae1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC
Application
ANDA202112
Marketing category
ANDA
Marketing start
2023-07-31
Substance
GLIMEPIRIDE
Active strength
1 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
A202112-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2013-04-17
A202112-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2013-04-17
A202112-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2013-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202112-001AB
A202112-002AB
A202112-003AB

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 UTC2026-02A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202112-002GLIMEPIRIDE2MGTABLET / ORALAB2013-04-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202112-003GLIMEPIRIDE4MGTABLET / ORALAB2013-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202112-001GLIMEPIRIDE1MGTABLET / ORALAB2013-04-178072bd15b7f6…

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 UTC2026-02A202112-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202112-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202112-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202112-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202112-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202112-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202112-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202112-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202112-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202112-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202112-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202112-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202112-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202112-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202112-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202112-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202112-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202112-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202112-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202112-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202112-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202112-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202112-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202112-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202112-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202112-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202112-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202112-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202112-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202112-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202112-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202112-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202112-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202112-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202112-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202112-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202112-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202112-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202112-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202112-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIMEPIRIDE1 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
8ff0de99-272e-4e68-9caf-69f3f146ac29Available 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
71921-214-01Glimepiride100 in 1 BOTTLETABLET1002
71921-214-50Glimepiride500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-214-01EA - Each71921-214dec77d2c-f228-4480-8dc4-917372897bc512023-09-05
71921-214-50EA - Each71921-2144702c078-bfef-4e34-bff4-adcbabdeb25412023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71921-214GLIMEPIRIDE TABLET [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]2Current NDC, 2 package rows20241022_8ff0de99-272e-4e68-9caf-69f3f146ac29.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
GlimepirideGLIMEPIRIDEPreferred Pharmaceuticals Inc.f69e36b9-4940-4f01-b5ea-59dc66dc1e872026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDECoupler LLC41bf4a72-9288-50a1-e063-6394a90a5e7c2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEREMEDYREPACK INC.c994796e-dd3d-4f40-a8f2-d317f55e34d52025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEREMEDYREPACK INC.95c59026-a2db-4579-b58c-b0a8e12e7f842025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEST. MARY'S MEDICAL PARK PHARMACY35ba31ef-2b90-61c6-e063-6394a90a59ee2025-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEA-S Medication Solutions49bf2d48-efa8-487b-b861-0124c3a4c9512025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEBryant Ranch Prepack661b5b13-6334-4965-8dc5-709e190805842025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEA-S Medication Solutions0c25c987-856f-448d-903a-e2c94049b0a72024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEA-S Medication Solutions79ee7533-f75d-4c49-b396-b339654f5c442024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEFlorida Pharmaceutical Products, LLC8ff0de99-272e-4e68-9caf-69f3f146ac292024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
ndc (product): 71921-214
GlimepirideGLIMEPIRIDEDirect_rx230949fd-563e-8dbf-e063-6394a90ab9b62024-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEA-S Medication Solutions1e5d562e-b3bf-4502-adc8-c89c8818a9bc2024-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEA-S Medication Solutions01196f54-32c8-41a0-b0ed-7968ca5d2fa22024-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDENuCare Pharmaceuticals,Inc.1c335fc7-24d0-5526-e063-6394a90a488e2024-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEBryant Ranch Prepack0b12d4ab-fa0c-44d5-888c-265dbb6615612024-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112
GlimepirideGLIMEPIRIDEBryant Ranch Prepackcdeda274-955b-413d-b2d4-b14d94f7d20c2024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202112
application number: ANDA202112

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN49bf2d48-efa8-487b-b861-0124c3a4c9514
199245glimepiride 1 MG Oral TabletSCD49bf2d48-efa8-487b-b861-0124c3a4c9514
199245glimepiride 1 MG Oral TabletPSN8ff0de99-272e-4e68-9caf-69f3f146ac292
199246glimepiride 2 MG Oral TabletPSN8ff0de99-272e-4e68-9caf-69f3f146ac292
199247glimepiride 4 MG Oral TabletPSN8ff0de99-272e-4e68-9caf-69f3f146ac292
199245glimepiride 1 MG Oral TabletSCD8ff0de99-272e-4e68-9caf-69f3f146ac292
199246glimepiride 2 MG Oral TabletSCD8ff0de99-272e-4e68-9caf-69f3f146ac292
199247glimepiride 4 MG Oral TabletSCD8ff0de99-272e-4e68-9caf-69f3f146ac292
199245glimepiride 1 MG Oral TabletPSN661b5b13-6334-4965-8dc5-709e190805841
199245glimepiride 1 MG Oral TabletSCD661b5b13-6334-4965-8dc5-709e190805841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71921-214-0171921021401100 TABLET in 1 BOTTLE (71921-214-01) 100 tablet2023-07-31NoNoCurrent
71921-214-5071921021450500 TABLET in 1 BOTTLE (71921-214-50) 500 tablet2023-07-31NoNoCurrent