FDA.reportPublic FDA data

Metformin HCL

Product NDC
72189-658
Requested package NDC
72189-658-82
11-digit product format
721890658
Labeler code
72189
Product ID
72189-658_4ce98cec-b62c-e8e8-e063-6394a90ac207
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA209882
Marketing category
ANDA
Marketing start
2026-01-29
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 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
A209882-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-27
A209882-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-27
A209882-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209882-001AB
A209882-002AB
A209882-003AB

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 22:54:322026-06A209882-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2018-08-27a50c72e98297…
2026-08-01 22:54:322026-06A209882-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2018-08-27a50c72e98297…
2026-08-01 22:54:322026-06A209882-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2018-08-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209882-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209882-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A209882-003AB1a50c72e98297…

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsf4fc759a-057e-4b5d-b8ab-13bc5eeb24e42026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions400ff9dc-9789-44ac-afb5-730b632a16672026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDELaurus Labs Limitedc3dfa8a1-d10a-4a1a-8eba-5f4e2a5a29492026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackbe023bca-511e-4801-bd2b-e30dd14087722026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HCLMETFORMIN HCLDirect_Rx498ac5fc-14be-d36a-e063-6394a90a30122026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
ndc (package): 72189-658-82
ndc (product): 72189-658
ndc11 (package): 72189065882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions8c248958-6c01-455e-89f5-959facb272ed2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsf59ceea4-a84a-4082-8e73-7c6f340c28d62026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions192970d3-826a-4b69-a525-9742794dc19c2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.ca71c133-6c38-4b9e-80af-1949634157f42026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLC0178b9dd-bafa-9e81-e063-6294a90a88b02026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.bfd6ec0f-8264-4877-aa6d-f347f53bc4262025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler LLC3eeee3b7-188a-05a0-e063-6294a90a18532025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.e1ebb146-acfd-4301-a79c-f5bb243f85752025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.33155746-c2ef-12f4-e063-6294a90a039c2025-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.0f251f2c-97f3-4048-84f2-81fea03685aa2025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepack286d959a-51cb-4dbd-a3e8-1ea2f00b54c72024-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepacked6e6f87-ddd7-4c9d-a263-47154d3a94782024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsc2783b59-7b20-4d4c-a3ca-03ed60dcf2c32024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions2be73d5e-7682-4ad3-831b-8c1ea73e38de2024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209882
application number: ANDA209882

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 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
861007Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
498ac5fc-14be-d36a-e063-6394a90a3012Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
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
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-658-30Metformin HCL30 in 1 BOTTLETABLET, FILM COATED303
72189-658-82Metformin HCL180 in 1 BOTTLETABLET, FILM COATED1803
72189-658-90Metformin HCL90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-658-30EA - Each72189-658d2460f8c-b9a5-4fad-8c80-20829b037a2412026-03-17
72189-658-82EA - Each72189-658050c4267-e75f-459b-b2fd-4a3ed022433812026-03-17
72189-658-90EA - Each72189-6588c5991df-9242-4c3e-bd2d-5d4242a05a6612026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861007metFORMIN HCl 500 MG Oral TabletPSN498ac5fc-14be-d36a-e063-6394a90a30123
861007metformin hydrochloride 500 MG Oral TabletSCD498ac5fc-14be-d36a-e063-6394a90a30123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-658-8272189065882180 TABLET, FILM COATED in 1 BOTTLE (72189-658-82) 2026-01-29NoNoCurrent