Glimepiride

Product NDC
16729-001
Requested package NDC
16729-001-01
11-digit product format
167290001
Labeler code
16729
Product ID
16729-001_415deb6c-47dc-ed2a-e063-6394a90a66fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc
Application
ANDA078181
Marketing category
ANDA
Marketing start
2007-08-23
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
A078181-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2007-08-23
A078181-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2007-08-23
A078181-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2007-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078181-001AB
A078181-002AB
A078181-003AB

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 UTC2026-02A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078181-002GLIMEPIRIDE2MGTABLET / ORALAB2007-08-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078181-003GLIMEPIRIDE4MGTABLET / ORALAB2007-08-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078181-001GLIMEPIRIDE1MGTABLET / ORALAB2007-08-238072bd15b7f6…

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 UTC2026-02A078181-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078181-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078181-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078181-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078181-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078181-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078181-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078181-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078181-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078181-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078181-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078181-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078181-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078181-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078181-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078181-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078181-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078181-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078181-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078181-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078181-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078181-001AB18072bd15b7f6…

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
9b74fbac-9e04-4927-9981-1e3dace89c6dAvailable 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
16729-001-01Glimepiride100 in 1 BOTTLETABLET10010
16729-001-16Glimepiride500 in 1 BOTTLETABLET50010
16729-001-17Glimepiride1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-001-01EA - Each16729-00172e554c4-b3db-49ed-8edd-1fec16eaa29312013-02-13
16729-001-16EA - Each16729-0011d24ee34-12a2-4ffa-9acf-56d35264abd612016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-001GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC]9Current NDC, Legacy NDC, 3 package rows20231129_9b74fbac-9e04-4927-9981-1e3dace89c6d.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDEBryant Ranch Prepack9e863f84-d6f2-4d61-8250-774569e843532026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.58c4261e-e98f-4280-9562-2800956dff142026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.1b3c7d74-f80b-4fb1-8dca-66880af5d3fc2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDENorthwind Health Company, LLC3e81a39a-30bb-4d6d-82e1-17d7134365be2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDENorthwind Health Company, LLCf2f2d6da-eb40-4290-e053-2a95a90a6ca02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEAccord Healthcare Inc9b74fbac-9e04-4927-9981-1e3dace89c6d2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
ndc (package): 16729-001-01
ndc (product): 16729-001
ndc11 (package): 16729000101
GlimepirideGLIMEPIRIDEProficient Rx LPbeb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEProficient Rx LP5a5747ea-cded-49ed-8807-dd3e2a1159e02022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181
GlimepirideGLIMEPIRIDEProficient Rx LP68cb4fcd-5bc3-4f53-9085-86df6a4246d62022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078181
application number: ANDA078181

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSNbf2f2303-19c6-4a93-b9ca-6efc1b4451241016
199245glimepiride 1 MG Oral TabletSCDbf2f2303-19c6-4a93-b9ca-6efc1b4451241016
199245glimepiride 1 MG Oral TabletPSN9b74fbac-9e04-4927-9981-1e3dace89c6d10
199246glimepiride 2 MG Oral TabletPSN9b74fbac-9e04-4927-9981-1e3dace89c6d10
199247glimepiride 4 MG Oral TabletPSN9b74fbac-9e04-4927-9981-1e3dace89c6d10
199245glimepiride 1 MG Oral TabletSCD9b74fbac-9e04-4927-9981-1e3dace89c6d10
199246glimepiride 2 MG Oral TabletSCD9b74fbac-9e04-4927-9981-1e3dace89c6d10
199247glimepiride 4 MG Oral TabletSCD9b74fbac-9e04-4927-9981-1e3dace89c6d10
199245glimepiride 1 MG Oral TabletPSN5a5747ea-cded-49ed-8807-dd3e2a1159e05
199245glimepiride 1 MG Oral TabletSCD5a5747ea-cded-49ed-8807-dd3e2a1159e05
199245glimepiride 1 MG Oral TabletPSN2b7f8d5f-ae07-4706-ac99-89e26c11321f2
199245glimepiride 1 MG Oral TabletSCD2b7f8d5f-ae07-4706-ac99-89e26c11321f2
199245glimepiride 1 MG Oral TabletPSN7d652e84-f0ed-0c6f-e053-2a91aa0a01611
199245glimepiride 1 MG Oral TabletPSN7f80bf43-18ae-1b1f-e053-2991aa0ace241
199245glimepiride 1 MG Oral TabletSCD7d652e84-f0ed-0c6f-e053-2a91aa0a01611
199245glimepiride 1 MG Oral TabletSCD7f80bf43-18ae-1b1f-e053-2991aa0ace241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-001-0116729000101100 TABLET in 1 BOTTLE (16729-001-01) 100 tablet2007-08-230000-00-00NoNoCurrent