FDA.reportPublic FDA data

glyburide-metformin hydrochloride

Product NDC
71335-2508
Requested package NDC
71335-2508-3
11-digit product format
713352508
Labeler code
71335
Product ID
71335-2508_e2fae12e-8044-43ad-994d-70ca0ad42174
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glyburide-metformin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079009
Marketing category
ANDA
Marketing start
2024-05-01
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

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
A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-03
A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-03
A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079009-001AB
A079009-002AB
A079009-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-03a50c72e98297…
2026-08-01 22:54:322026-06A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-03a50c72e98297…
2026-08-01 22:54:322026-06A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079009-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A079009-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A079009-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEBryant Ranch Prepackb5ccf5da-cbe1-4009-ba1c-990050838ee92026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079009
application number: ANDA079009
ndc (package): 71335-2508-3
ndc (product): 71335-2508
ndc11 (package): 71335250803
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEBryant Ranch Prepacka086cc29-cb5d-40d0-a57d-8e91f1aa91582026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079009
application number: ANDA079009
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b38213bb-d663-4c95-a1b2-96c23ee5be092026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079009
application number: ANDA079009
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEA-S Medication Solutionsf43c087a-7135-4a79-8463-fe5e9319da912026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079009
application number: ANDA079009
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.a0ff8ee6-0da8-40f8-b5b0-a7b334e1a15f2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079009
application number: ANDA079009
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.486fec17-ff83-3bab-e063-6394a90a5ef02026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079009
application number: ANDA079009
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEA-S Medication Solutionsfaa19e1b-2782-4bf1-a93f-84755f7aa53f2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079009
application number: ANDA079009

Additional Listing Data#

Finished product
Yes
Brand name base
glyburide-metformin hydrochloride
Listing expiration
2027-12-31

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
b5ccf5da-cbe1-4009-ba1c-990050838ee9Available 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
71335-2508-1glyburide-metformin hydrochloride30 in 1 BOTTLETABLET301
71335-2508-3glyburide-metformin hydrochloride60 in 1 BOTTLETABLET601
71335-2508-4glyburide-metformin hydrochloride90 in 1 BOTTLETABLET901
71335-2508-5glyburide-metformin hydrochloride120 in 1 BOTTLETABLET1201
71335-2508-6glyburide-metformin hydrochloride100 in 1 BOTTLETABLET1001
71335-2508-7glyburide-metformin hydrochloride180 in 1 BOTTLETABLET1801
71335-2508-8glyburide-metformin hydrochloride25 in 1 BOTTLETABLET251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2508-1EA - Each71335-250894fa6bc8-ec92-4f95-95fa-4230006fe5a012025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2508GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1Current NDC, 7 package rows20241023_b5ccf5da-cbe1-4009-ba1c-990050838ee9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861753glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral TabletPSNb5ccf5da-cbe1-4009-ba1c-990050838ee91
861753glyburide 5 MG / metformin hydrochloride 500 MG Oral TabletSCDb5ccf5da-cbe1-4009-ba1c-990050838ee91
861753glyburide 5 MG / metformin HCl 500 MG Oral TabletSYb5ccf5da-cbe1-4009-ba1c-990050838ee91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2508-37133525080360 TABLET in 1 BOTTLE (71335-2508-3) 60 tablet2024-10-21NoNoCurrent