FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
59651-855
11-digit product format
596510855
Labeler code
59651
Product ID
59651-855_0bfb57c0-6114-4734-a8d7-b78102e7f8eb
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
2024-03-29
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

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 Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui861004, 861007, 861010

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
59651-855-01Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1003
59651-855-05Metformin Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5003
59651-855-26Metformin Hydrochloride2500 in 1 BOTTLETABLET, FILM COATED25003
59651-855-50Metformin Hydrochloride50 in 1 BOTTLETABLET, FILM COATED503
59651-855-60Metformin Hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
59651-855-79Metformin Hydrochloride300 in 1 BOTTLETABLET, FILM COATED3003
59651-855-90Metformin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903
59651-855-99Metformin Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-855-01EA - Each59651-855daadb2db-5888-4363-86c7-5e718a78a8ac12025-02-10
59651-855-05EA - Each59651-8552bb09ea0-7a15-407a-93d8-0b1984cf814e12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-855METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2Current NDC, 8 package rows20241225_fc466c46-abaa-4675-aef2-4b1a1adfd912.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN0448c618-2f0d-4ed3-866f-74b413cf902d6
861007metFORMIN HCl 500 MG Oral TabletPSN0448c618-2f0d-4ed3-866f-74b413cf902d6
861010metFORMIN HCl 850 MG Oral TabletPSN0448c618-2f0d-4ed3-866f-74b413cf902d6
861004metformin hydrochloride 1000 MG Oral TabletSCD0448c618-2f0d-4ed3-866f-74b413cf902d6
861007metformin hydrochloride 500 MG Oral TabletSCD0448c618-2f0d-4ed3-866f-74b413cf902d6
861010metformin hydrochloride 850 MG Oral TabletSCD0448c618-2f0d-4ed3-866f-74b413cf902d6
861004metformin HCl 1 GM Oral TabletSY0448c618-2f0d-4ed3-866f-74b413cf902d6
861004metFORMIN HCl 1000 MG Oral TabletPSNfc466c46-abaa-4675-aef2-4b1a1adfd9123
861007metFORMIN HCl 500 MG Oral TabletPSNfc466c46-abaa-4675-aef2-4b1a1adfd9123
861010metFORMIN HCl 850 MG Oral TabletPSNfc466c46-abaa-4675-aef2-4b1a1adfd9123
861004metformin hydrochloride 1000 MG Oral TabletSCDfc466c46-abaa-4675-aef2-4b1a1adfd9123
861007metformin hydrochloride 500 MG Oral TabletSCDfc466c46-abaa-4675-aef2-4b1a1adfd9123
861010metformin hydrochloride 850 MG Oral TabletSCDfc466c46-abaa-4675-aef2-4b1a1adfd9123
861004metformin HCl 1 GM Oral TabletSYfc466c46-abaa-4675-aef2-4b1a1adfd9123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-855-0159651085501100 TABLET, FILM COATED in 1 BOTTLE (59651-855-01) 2024-03-29NoNoCurrent
59651-855-0559651085505500 TABLET, FILM COATED in 1 BOTTLE (59651-855-05) 2024-03-29NoNoCurrent
59651-855-26596510855262500 TABLET, FILM COATED in 1 BOTTLE (59651-855-26) 2024-03-29NoNoCurrent
59651-855-29596510855291500 TABLET, FILM COATED in 1 BAG (59651-855-29)29-MAR-24Current
59651-855-505965108555050 TABLET, FILM COATED in 1 BOTTLE (59651-855-50) 2024-03-29NoNoCurrent
59651-855-605965108556060 TABLET, FILM COATED in 1 BOTTLE (59651-855-60) 2024-03-29NoNoCurrent
59651-855-7959651085579300 TABLET, FILM COATED in 1 BOTTLE (59651-855-79) 2024-03-29NoNoCurrent
59651-855-905965108559090 TABLET, FILM COATED in 1 BOTTLE (59651-855-90) 2024-03-29NoNoCurrent
59651-855-99596510855991000 TABLET, FILM COATED in 1 BOTTLE (59651-855-99) 2024-03-29NoNoCurrent