FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
72789-400
Requested package NDC
72789-400-01
11-digit product format
727890400
Labeler code
72789
Product ID
72789-400_3cf82ef5-5b60-2c45-e063-6394a90a5d62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA201991
Marketing category
ANDA
Marketing start
2013-03-01
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201991-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201991-001AB1

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 22:54:322026-06A201991-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12012-01-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201991-001AB11a50c72e98297…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9171d369-d35a-40e4-a9ad-26484e66fc5e2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
ndc (package): 72789-400-01
ndc (product): 72789-400
ndc11 (package): 72789040001
METFORMIN HYDROCHLORIDE ERMETFORMIN HYDROCHLORIDELeading Pharma, LLC3dca884d-ec44-496f-9eeb-31fd8fa3f5742026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAscend Laboratories, LLCa944a167-e3ac-4084-af1c-22b48713471c2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQPharma Inc5269e91f-7e93-9405-e063-6294a90a32172026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP3ba957ea-28ed-4a61-a318-98064ea4944d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENorthwind Health Company, LLC07d8a69f-30d9-7511-e063-6394a90a95ca2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
Metformin hydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.4be72741-4f6d-6689-e054-00144ff8d46c2025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepackf2318509-9a49-4c99-a08b-22381f17aacd2025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f55a245b-a786-4a4a-b11c-c61d48294b012025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions0cd086d6-3ae2-476e-b93e-29055e67e8fc2025-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutionsa434b937-2648-4509-8ce8-94a28582ec772025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions784a6bbd-4f13-45ed-89c1-154b06721ed02025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.4adeddf2-f449-4a61-9658-dfbff7c502302025-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs5bb945c1-954a-4d43-aa24-33767d19c57c2024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1a047fc0-196e-79af-e063-6394a90a1e0d2024-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201991
application number: ANDA201991

Additional Listing Data#

Finished product
Yes
Brand name base
METFORMIN HYDROCHLORIDE
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
860975Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9171d369-d35a-40e4-a9ad-26484e66fc5eAvailable 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
72789-400-01METFORMIN HYDROCHLORIDE100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10014
72789-400-60METFORMIN HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE6014
72789-400-82METFORMIN HYDROCHLORIDE500 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE50014
72789-400-86METFORMIN HYDROCHLORIDE360 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE36014
72789-400-90METFORMIN HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE9014
72789-400-93METFORMIN HYDROCHLORIDE180 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE18014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-400-01EA - Each72789-400a6a3ddb2-8d28-4976-9ed2-bd8aafebd94a12025-02-10
72789-400-60EA - Each72789-4001dbfda39-cf27-4142-8d50-37ef3e4cf1d412024-07-12
72789-400-82EA - Each72789-40024083d02-a2f4-4a61-be90-b470b040d75512024-07-12
72789-400-86EA - Each72789-4003392c6e6-4894-4ca3-b83d-e1c8db11da5712024-06-10
72789-400-90EA - Each72789-40075836731-2edf-405f-9fba-a8ee5a4133cf12024-06-10
72789-400-93EA - Each72789-400b88a90ea-d207-4f7f-9e99-726ec99b95c412024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-400METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12Current NDC, 6 package rows20250116_9171d369-d35a-40e4-a9ad-26484e66fc5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN9171d369-d35a-40e4-a9ad-26484e66fc5e14
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD9171d369-d35a-40e4-a9ad-26484e66fc5e14
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY9171d369-d35a-40e4-a9ad-26484e66fc5e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-400-0172789040001100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-400-01) 2025-01-15NoNoCurrent