FDA.reportPublic FDA data

Glyburide and Metformin Hydrochloride

Product NDC
71335-0360
Requested package NDC
71335-0360-5
11-digit product format
713350360
Labeler code
71335
Product ID
71335-0360_070b40e6-7d48-4193-a3c5-2599e3e6dbaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide and Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077870
Marketing category
ANDA
Marketing start
2007-11-14
Substance
GLYBURIDE; METFORMIN HYDROCHLORIDE
Active strength
5; 500 mg/1; mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 packagepackage71335-036071335-0360-5DDiscontinued by firm2026-08-03

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
A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-14
A077870-002GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALABRS2007-11-14
A077870-003GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2007-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077870-001AB
A077870-002AB
A077870-003AB

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 UTC2026-02A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077870-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALABRS2007-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077870-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2007-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077870-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALABRS2007-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077870-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2007-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077870-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALABRS2007-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077870-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2007-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077870-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALABRS2007-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077870-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2007-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077870-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALABRS2007-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077870-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2007-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077870-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALABRS2007-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077870-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2007-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077870-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALABRS2007-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077870-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2007-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077870-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALABRS2007-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077870-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2007-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077870-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALABRS2007-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077870-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2007-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A077870-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALABRS2007-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A077870-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2007-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077870-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALABRS2007-11-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077870-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2007-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077870-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALABRS2007-11-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077870-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2007-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077870-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALABRS2007-11-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077870-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2007-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077870-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2007-11-148072bd15b7f6…

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 UTC2026-02A077870-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077870-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077870-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077870-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077870-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077870-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077870-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077870-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077870-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077870-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077870-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077870-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077870-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077870-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077870-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077870-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077870-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077870-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077870-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077870-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077870-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077870-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077870-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077870-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077870-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077870-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077870-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077870-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077870-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077870-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077870-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077870-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077870-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077870-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077870-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077870-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077870-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077870-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077870-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077870-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Glyburide and Metformin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYBURIDE5 mg/1
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SX6K58TVWCInternal UNII lookup
786Z46389EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861753Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4dcef36f-000e-43f5-8d67-0e2a079ab2c6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5Product name720250515
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
ca3f036c-6c06-b829-b379-1a3a4097099cProduct name920180605
e1ede89f-54c8-428f-ae84-9e8a2deb67dbProduct name120180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
64b2b6e2-1c04-cf4a-db4c-078ed10e1dd6Product name220160609
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
5a2baaae-1290-c05e-207f-b1367e9eb46aProduct name220151005
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7Product name120150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0Product name120141205
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
b044018d-bcdc-e68d-63da-1ad6886aea64Product name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0360-1Glyburide and Metformin Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30105
71335-0360-3Glyburide and Metformin Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60105
71335-0360-4Glyburide and Metformin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90105
71335-0360-5Glyburide and Metformin Hydrochloride120 in 1 BOTTLETABLET, FILM COATED120105
71335-0360-6Glyburide and Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100105
71335-0360-7Glyburide and Metformin Hydrochloride180 in 1 BOTTLETABLET, FILM COATED180105
71335-0360-8Glyburide and Metformin Hydrochloride25 in 1 BOTTLETABLET, FILM COATED25105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0360GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 7 package rows20240822_4dcef36f-000e-43f5-8d67-0e2a079ab2c6.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDERising Pharma Holdings, Inc.372af566-d6ec-446f-88db-0b4cc83b577f2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077870
application number: ANDA077870
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEAurobindo Pharma Limited7010b662-8b34-49ce-8e5b-73dee0821a602026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077870
application number: ANDA077870
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.a58ff524-e975-4d51-a896-e869f8ea66242026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077870
application number: ANDA077870
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.c284c146-436b-4eea-9dca-d7d21c82778c2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077870
application number: ANDA077870
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsd87dade1-55fe-4e77-91b9-b642022a2b8a2026-02-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077870
application number: ANDA077870
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDENorthwind Health Company, LLCadb751e0-19f6-3f41-e053-2a95a90a2df82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077870
application number: ANDA077870
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.d2b109e4-b743-4c5b-98fa-8e1ff4491dd02025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077870
application number: ANDA077870
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepack4dcef36f-000e-43f5-8d67-0e2a079ab2c62024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077870
application number: ANDA077870
ndc (package): 71335-0360-5
ndc (product): 71335-0360
ndc11 (package): 71335036005
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.7facb5ac-c1d5-43b4-e053-2991aa0a2a7b2024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077870
application number: ANDA077870
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepack8f2951ab-20c3-4216-b250-4c6a62d322032024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077870
application number: ANDA077870

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861753glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral TabletPSN4dcef36f-000e-43f5-8d67-0e2a079ab2c6105
861753glyburide 5 MG / metformin hydrochloride 500 MG Oral TabletSCD4dcef36f-000e-43f5-8d67-0e2a079ab2c6105
861753glyburide 5 MG / metformin HCl 500 MG Oral TabletSY4dcef36f-000e-43f5-8d67-0e2a079ab2c6105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0360-571335036005120 TABLET, FILM COATED in 1 BOTTLE (71335-0360-5) 2024-05-290000-00-00NoNoCurrent