FDA.reportPublic FDA data

Metformin HCl

Product NDC
50090-3050
11-digit product format
500903050
Labeler code
50090
Product ID
50090-3050_91dc93c6-0c9f-43b1-944f-231bf12230a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin HCl
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090564
Marketing category
ANDA
Marketing start
2017-02-06
Substance
METFORMIN HYDROCHLORIDE
Active strength
850 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
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
A090564-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-22
A090564-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-22
A090564-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090564-001AB
A090564-002AB
A090564-003AB

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 22:54:322026-06A090564-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-04-22a50c72e98297…
2026-08-01 22:54:322026-06A090564-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-04-22a50c72e98297…
2026-08-01 22:54:322026-06A090564-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALABRS2010-04-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090564-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A090564-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A090564-003AB1a50c72e98297…

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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.30658e19-8e6e-49aa-a007-e414224797c52026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECardinal Health 107, LLC46cb7e3f-c739-433d-9dbe-427c2d95bef12026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.5aa1c86c-f2c8-49b1-8f81-47b11386c5d32026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HClMETFORMIN HCLPD-Rx Pharmaceuticals, Inc.fb890205-5d43-41eb-97b2-fb0dcdd3a9502026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE TABLETGranules India Ltd8cd5555c-f6b2-28d8-e053-2a95a90a5f1e2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HClMETFORMIN HCLUnit Dose Solutions, Inc.5538e9df-0983-9281-e063-6394a90a92492026-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEUnit Dose Solutions, Inc.552ad61d-bafd-478d-e063-6294a90a02f92026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HClMETFORMIN HCLUnit Dose Solutions, Inc.552df462-6dcb-e6f2-e063-6294a90aacfe2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMajor Pharmaceuticals5e783025-bf6d-465e-bf58-bcd253afad2c2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c32026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.902d1bc4-3f1f-4a1a-86d7-cf98c56a36842026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.33550b88-d4bb-4ce6-a7db-07c966f6984f2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler LLC53e950f5-c58f-78e3-e063-6294a90a53e92026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HClMETFORMIN HCLProficient Rx LPd2c927eb-12bf-4c7d-9ef5-0036b2dd8c292026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HClMETFORMIN HCLNorthwind Health Company, LLC13b1e35f-d047-8ddc-e063-6394a90a24dd2026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler LLC51285096-e2ce-0f3c-e063-6394a90a35d42026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEGranules Pharmaceuticals Inc.2387a618-24d8-4813-aa83-9114edb353742026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.59a4ccda-5487-4ac4-9373-0c0fc8b7c88b2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564
Metformin hydrochlorideMETFORMIN HYDROCHLORIDELegacy Pharmaceutical Packaging, LLCb51da8d7-ab4a-4c40-97c9-88bd379366d12026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090564
application number: ANDA090564

Additional Listing Data#

Finished product
Yes
Brand name base
Metformin HCl
Listing expiration
2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
c37b511c-1e33-4941-bd12-df0447a50ca9Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3050-02023-02-07C16284748780-1f386c649-d1d7-0266-e053-dadaa90a7c1aMetformin Hydrochloride Tablets USP
50090-3050-22023-02-07C16284748780-1f386c649-d1d7-0266-e053-dadaa90a7c1aMetformin Hydrochloride Tablets USP
50090-3050-42023-02-07C16284748780-1f386c649-d1d7-0266-e053-dadaa90a7c1aMetformin Hydrochloride Tablets USP
50090-3050-52023-02-07C16284748780-1f386c649-d1d7-0266-e053-dadaa90a7c1aMetformin Hydrochloride Tablets USP
50090-3050-02023-01-30C16284748780-1f386c649-d1d7-0266-e053-dadaa90a7c1aMetformin Hydrochloride Tablets USP
50090-3050-22023-01-30C16284748780-1f386c649-d1d7-0266-e053-dadaa90a7c1aMetformin Hydrochloride Tablets USP
50090-3050-42023-01-30C16284748780-1f386c649-d1d7-0266-e053-dadaa90a7c1aMetformin Hydrochloride Tablets USP
50090-3050-52023-01-30C16284748780-1f386c649-d1d7-0266-e053-dadaa90a7c1aMetformin Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3050-0Metformin HCl60 in 1 BOTTLETABLET6018
50090-3050-2Metformin HCl100 in 1 BOTTLETABLET10018
50090-3050-4Metformin HCl90 in 1 BOTTLE, PLASTICTABLET9018
50090-3050-5Metformin HCl180 in 1 BOTTLETABLET18018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3050-0EA - Each50090-30507e56dd32-bb8a-4da1-9fa1-946b7061a57112019-05-02
50090-3050-2EA - Each50090-3050416a9c4e-9634-44a7-b97c-2ef2e0546a8412019-05-02
50090-3050-4EA - Each50090-3050d31a3670-f6fc-4e19-be8a-ca558ef1e9b312019-05-02
50090-3050-5EA - Each50090-3050bbc33f96-f0a5-47fa-b025-e94cbeae935d12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3050METFORMIN HCL TABLET [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 4 package rows20240518_c37b511c-1e33-4941-bd12-df0447a50ca9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861010metFORMIN HCl 850 MG Oral TabletPSNc37b511c-1e33-4941-bd12-df0447a50ca918
861010metformin hydrochloride 850 MG Oral TabletSCDc37b511c-1e33-4941-bd12-df0447a50ca918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3050-05009030500060 TABLET in 1 BOTTLE (50090-3050-0) 60 tablet2017-07-170000-00-00NoNoCurrent
50090-3050-250090305002100 TABLET in 1 BOTTLE (50090-3050-2) 100 tablet2017-06-270000-00-00NoNoCurrent
50090-3050-45009030500490 TABLET in 1 BOTTLE, PLASTIC (50090-3050-4) 90 tablet2017-02-060000-00-00NoNoCurrent
50090-3050-550090305005180 TABLET in 1 BOTTLE (50090-3050-5) 180 tablet2018-09-050000-00-00NoNoCurrent