Glimepiride

Product NDC
69452-130
11-digit product format
694520130
Labeler code
69452
Product ID
69452-130_f7511fbc-d31b-4338-9109-a774bba0d4f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA091220
Marketing category
ANDA
Marketing start
2015-10-01
Marketing end
2020-02-29
Substance
GLIMEPIRIDE
Active strength
4 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69452-130DDiscontinued by firm2026-08-17
excluded packagepackage69452-13069452-130-20DDiscontinued by firm2026-08-17
excluded packagepackage69452-13069452-130-30DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69452-130-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69452-130-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69452-130-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69452-130-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69452-130-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69452-130-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69452-130-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69452-130-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69452-130-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69452-130-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69452-130-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69452-130-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69452-130-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69452-130-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69452-130-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69452-130-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69452-130-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69452-130-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69452-130-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69452-130-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69452-130-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69452-130-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69452-130-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69452-130-20557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091220-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2012-06-29
A091220-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2012-06-29
A091220-003GLIMEPIRIDEGLIMEPIRIDE3MGTABLET / ORAL2012-06-29
A091220-004GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2012-06-29
A091220-005GLIMEPIRIDEGLIMEPIRIDE6MGTABLET / ORAL2012-06-29
A091220-006GLIMEPIRIDEGLIMEPIRIDE8MGTABLET / ORALAB2012-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A091220-001AB
A091220-002AB
A091220-004AB
A091220-006AB

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 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-005GLIMEPIRIDE6MGTABLET / ORAL2012-06-29caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-006GLIMEPIRIDE8MGTABLET / ORALAB2012-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-005GLIMEPIRIDE6MGTABLET / ORAL2012-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-006GLIMEPIRIDE8MGTABLET / ORALAB2012-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-005GLIMEPIRIDE6MGTABLET / ORAL2012-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-006GLIMEPIRIDE8MGTABLET / ORALAB2012-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-005GLIMEPIRIDE6MGTABLET / ORAL2012-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-006GLIMEPIRIDE8MGTABLET / ORALAB2012-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-005GLIMEPIRIDE6MGTABLET / ORAL2012-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-006GLIMEPIRIDE8MGTABLET / ORALAB2012-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-005GLIMEPIRIDE6MGTABLET / ORAL2012-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-006GLIMEPIRIDE8MGTABLET / ORALAB2012-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-001GLIMEPIRIDE1MGTABLET / ORALAB2012-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-002GLIMEPIRIDE2MGTABLET / ORALAB2012-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-003GLIMEPIRIDE3MGTABLET / ORAL2012-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-004GLIMEPIRIDE4MGTABLET / ORALAB2012-06-2903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091220-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091220-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091220-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091220-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091220-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091220-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091220-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091220-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091220-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091220-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091220-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091220-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091220-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091220-006AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091220-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091220-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091220-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091220-006AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091220-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091220-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091220-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091220-006AB1d8e5a09893c0…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-130-20EA - Each69452-13033b6c5dc-0544-48f9-98fa-5d3be04b01f612016-02-04
69452-130-30EA - Each69452-1307b743ef2-4caa-4c29-9263-f68f3bd62cec12016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [BIONPHARMA INC.]1
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [BIONPHARMA INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [BIONPHARMA INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGLIMEPIRIDE TABLET [BIONPHARMA INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [BIONPHARMA INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLIMEPIRIDE TABLET [BIONPHARMA INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [BIONPHARMA INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [BIONPHARMA INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XGLIMEPIRIDE TABLET [BIONPHARMA INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGLIMEPIRIDE TABLET [BIONPHARMA INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [BIONPHARMA INC.]1

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDEBryant Ranch Prepack62780d2e-083d-4bcb-99ff-1b1b4ade60d92026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091220
application number: ANDA091220
GlimepirideGLIMEPIRIDEBluePoint Laboratoriesa01b0466-13f5-4c47-ae55-c5f1527d94142025-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091220
application number: ANDA091220
GlimepirideGLIMEPIRIDEBryant Ranch Prepackd4513181-4558-4d9a-851b-acf7e3eda25a2025-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091220
application number: ANDA091220
GlimepirideGLIMEPIRIDEMicro Labs Limited60e9397e-83b9-489e-9683-6f87e458bbaa2025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091220
application number: ANDA091220
Glimepiride 3 mgGLIMEPIRIDELifsa Drugs LLC51157849-7990-4a8b-ae50-eda1baf93cfa2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091220
application number: ANDA091220
GlimepirideGLIMEPIRIDENCS HealthCare of KY, Inc dba Vangard Labs669a67c2-2f97-4b7e-8bba-83a015e0fa942020-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091220
application number: ANDA091220

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN9bbfd55a-c88f-48b6-b18f-7d3d83c261581
199247glimepiride 4 MG Oral TabletSCD9bbfd55a-c88f-48b6-b18f-7d3d83c261581