GLIMEPIRIDE

Product NDC
60760-230
Requested package NDC
60760-230-90
11-digit product format
607600230
Labeler code
60760
Product ID
60760-230_a23cdd03-157a-0a4f-e053-2995a90a10ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLIMEPIRIDE
Dosage form
TABLET
Route
ORAL
Labeler
St Marys Medical Park Pharmacy
Application
ANDA077091
Marketing category
ANDA
Marketing start
2013-05-09
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
4 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60760-23060760-230-90DDiscontinued by firm2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-230-30EA - Each60760-23078dee53a-9e26-45ac-90b3-e3a28e51dafe12013-06-04
60760-230-90EA - Each60760-230a80a2d14-10a0-4cb9-89b2-3273dbdf4c6d12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]2
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XGLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]2

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-230-906076002309090 TABLET in 1 BOTTLE, PLASTIC (60760-230-90) 90 tablet2020-03-310000-00-00NoNoCurrent