FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
65862-009
Requested package NDC
65862-009-99
11-digit product format
658620009
Labeler code
65862
Product ID
65862-009_1c59d7bc-6118-4707-80c0-886ac00bab09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077095
Marketing category
ANDA
Marketing start
2005-01-14
Substance
METFORMIN HYDROCHLORIDE
Active strength
850 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A077095-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-14
A077095-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-14
A077095-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077095-001AB
A077095-002AB
A077095-003AB

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 22:54:322026-06A077095-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-01-14a50c72e98297…
2026-08-01 22:54:322026-06A077095-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-01-14a50c72e98297…
2026-08-01 22:54:322026-06A077095-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-01-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077095-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077095-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077095-003AB1a50c72e98297…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limited4ac6d01a-af26-44e7-ae2e-3618de0080aa2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
ndc (package): 65862-009-99
ndc (product): 65862-009
ndc11 (package): 65862000999
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limitedfc466c46-abaa-4675-aef2-4b1a1adfd9122026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.5d8d654a-9bb4-4c87-ab43-c21c4e8747082026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackfb296500-55cb-45ce-be0c-59aa2e3d46242026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.073cf6d9-7142-4d8b-898e-174c62a1f76f2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs0448c618-2f0d-4ed3-866f-74b413cf902d2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1d7556eb-82b4-4085-b0b1-dc061b216feb2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLCdb113f46-6fac-9005-e053-2995a90a017a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3d450933-8d9d-27de-e063-6294a90ae6d92025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3ab4efb6-bd30-2583-e063-6294a90a415b2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions23aa50c5-28fe-4322-b5c6-1f1c48409b162025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC390c3bdf-bfaf-203e-e063-6394a90a7d202025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs23aa0072-365c-4d13-9aa7-ae23f7e00ee42024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f62024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsafb183f6-a13c-4f00-82d5-9fe336173d342024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP1b9b6db9-1bac-4252-a03c-18dc0271f05f2023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077095
application number: ANDA077095

Additional Listing Data#

Finished product
Yes
Brand name base
Metformin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE850 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861004Internal RxNorm lookup
861007Internal RxNorm lookup
861010Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ac6d01a-af26-44e7-ae2e-3618de0080aaAvailable 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
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
65862-009-01Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10016
65862-009-05Metformin Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50016
65862-009-33Metformin Hydrochloride300 in 1 BOTTLETABLET, FILM COATED30016
65862-009-44Metformin Hydrochloride2500 in 1 BOTTLETABLET, FILM COATED250016
65862-009-50Metformin Hydrochloride50 in 1 BOTTLETABLET, FILM COATED5016
65862-009-60Metformin Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6016
65862-009-90Metformin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9016
65862-009-99Metformin Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-009-01EA - Each65862-009c80a1277-357f-492b-8939-5a32c988d9b912012-07-24
65862-009-05EA - Each65862-009d57037f1-ff0f-4437-9959-fd9aec485e4612012-07-24
65862-009-90EA - Each65862-00941280c70-d783-4693-8a19-77c95bb4961b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
HYPROMELLOSE 2910 (5 CPS)INACTIVE INGREDIENTR75537T0T4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-009METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15Current NDC, Legacy NDC, 8 package rows20240104_4ac6d01a-af26-44e7-ae2e-3618de0080aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861007metFORMIN HCl 500 MG Oral TabletPSN23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861010metFORMIN HCl 850 MG Oral TabletPSN23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861004metformin hydrochloride 1000 MG Oral TabletSCD23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861007metformin hydrochloride 500 MG Oral TabletSCD23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861010metformin hydrochloride 850 MG Oral TabletSCD23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861004metformin HCl 1 GM Oral TabletSY23aa50c5-28fe-4322-b5c6-1f1c48409b1638
861004metFORMIN HCl 1000 MG Oral TabletPSN4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861007metFORMIN HCl 500 MG Oral TabletPSN4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861010metFORMIN HCl 850 MG Oral TabletPSN4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861004metformin hydrochloride 1000 MG Oral TabletSCD4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861007metformin hydrochloride 500 MG Oral TabletSCD4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861010metformin hydrochloride 850 MG Oral TabletSCD4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861004metformin HCl 1 GM Oral TabletSY4ac6d01a-af26-44e7-ae2e-3618de0080aa16
861004metFORMIN HCl 1000 MG Oral TabletPSN23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861007metFORMIN HCl 500 MG Oral TabletPSN23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861010metFORMIN HCl 850 MG Oral TabletPSN23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861004metformin hydrochloride 1000 MG Oral TabletSCD23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861007metformin hydrochloride 500 MG Oral TabletSCD23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861010metformin hydrochloride 850 MG Oral TabletSCD23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861004metformin HCl 1 GM Oral TabletSY23aa0072-365c-4d13-9aa7-ae23f7e00ee415
861010metFORMIN HCl 850 MG Oral TabletPSN5742fd25-09c5-4264-99c1-249ab823d3cd1
861010metformin hydrochloride 850 MG Oral TabletSCD5742fd25-09c5-4264-99c1-249ab823d3cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-009-99658620009991000 TABLET, FILM COATED in 1 BOTTLE (65862-009-99) 2005-01-140000-00-00NoNoCurrent