FDA.reportPublic FDA data

Glipizide and Metformin Hydrochloride

Product NDC
65841-661
11-digit product format
658410661
Labeler code
65841
Product ID
65841-661_62c55ebc-1883-4bfb-a772-2614c99a2fec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide and Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA078905
Marketing category
ANDA
Marketing start
2016-05-05
Substance
GLIPIZIDE; 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 43.

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
A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-31
A078905-002GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2011-01-31
A078905-003GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2011-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078905-001AB
A078905-002AB
A078905-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-3184e616aacf4f…
2026-09-14 22:38:342026-08A078905-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2011-01-3184e616aacf4f…
2026-09-14 22:38:342026-08A078905-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2011-01-3184e616aacf4f…
2026-08-18 06:07:402026-07A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A078905-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2011-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A078905-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2011-01-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078905-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2011-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078905-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2011-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078905-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2011-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078905-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2011-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078905-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2011-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078905-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2011-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078905-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2011-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078905-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2011-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078905-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2011-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078905-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2011-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078905-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2011-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078905-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2011-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078905-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2011-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078905-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2011-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078905-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2011-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078905-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2011-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078905-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2011-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078905-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2011-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A078905-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2011-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A078905-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2011-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078905-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2011-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078905-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2011-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078905-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2011-01-31301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078905-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078905-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078905-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078905-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078905-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078905-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078905-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078905-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078905-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078905-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078905-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078905-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078905-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078905-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078905-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078905-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078905-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078905-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078905-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078905-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078905-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078905-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078905-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078905-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078905-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078905-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078905-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078905-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078905-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078905-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078905-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078905-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078905-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078905-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078905-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078905-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078905-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078905-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078905-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078905-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIPIZIDE5 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
786Z46389EInternal UNII lookup
X7WDT95N5CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861731Internal RxNorm lookup
861736Internal RxNorm lookup
861740Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bd2e1c06-424b-4222-b723-90ffdcc3983cAvailable 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
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09Product name220250625
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
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
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
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
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
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-661-01Glipizide and Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1007
65841-661-10Glipizide and Metformin Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10007
65841-661-16Glipizide and Metformin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED907
65841-661-30Glipizide and Metformin Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED107
65841-661-77Glipizide and Metformin Hydrochloride10 in 1 CARTONTABLET, FILM COATED107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-661GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]7Current NDC, Legacy NDC, 5 package rows20241201_bd2e1c06-424b-4222-b723-90ffdcc3983c.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.1b18b903-eb52-4d08-b4a5-f984957eb1162026-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078905
application number: ANDA078905
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEA-S Medication Solutions4a2d814b-93a1-4487-b789-dbafe9f0ffd32026-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078905
application number: ANDA078905
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limitedbd2e1c06-424b-4222-b723-90ffdcc3983c2024-11-30Exact identifier
application applno (ANDA): 078905
application number: ANDA078905
ndc (product): 65841-661

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861731glipiZIDE 2.5 MG / metFORMIN HCl 250 MG Oral TabletPSNbd2e1c06-424b-4222-b723-90ffdcc3983c7
861736glipiZIDE 2.5 MG / metFORMIN HCl 500 MG Oral TabletPSNbd2e1c06-424b-4222-b723-90ffdcc3983c7
861740glipiZIDE 5 MG / metFORMIN HCl 500 MG Oral TabletPSNbd2e1c06-424b-4222-b723-90ffdcc3983c7
861731glipizide 2.5 MG / metformin hydrochloride 250 MG Oral TabletSCDbd2e1c06-424b-4222-b723-90ffdcc3983c7
861736glipizide 2.5 MG / metformin hydrochloride 500 MG Oral TabletSCDbd2e1c06-424b-4222-b723-90ffdcc3983c7
861740glipizide 5 MG / metformin hydrochloride 500 MG Oral TabletSCDbd2e1c06-424b-4222-b723-90ffdcc3983c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-661-0165841066101100 TABLET, FILM COATED in 1 BOTTLE (65841-661-01) 2016-05-050000-00-00NoNoCurrent
65841-661-10658410661101000 TABLET, FILM COATED in 1 BOTTLE (65841-661-10) 2016-05-050000-00-00NoNoCurrent
65841-661-166584106611690 TABLET, FILM COATED in 1 BOTTLE (65841-661-16) 2016-05-050000-00-00NoNoCurrent
65841-661-306584106613010 in 1 BLISTER PACKHistorical
65841-661-776584106617710 BLISTER PACK in 1 CARTON (65841-661-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-661-30) 10 blister pack2016-05-050000-00-00NoNoCurrent