FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
50228-105
11-digit product format
502280105
Labeler code
50228
Product ID
50228-105_f1d709ff-59a3-841a-e053-2a95a90a9c29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals Inc
Application
ANDA203769
Marketing category
ANDA
Marketing start
2015-02-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
METFORMIN HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-105-00METFORMIN HYDROCHLORIDE9000 in 1 BOTTLETABLET90009
50228-105-01METFORMIN HYDROCHLORIDE100 in 1 BOTTLETABLET1009
50228-105-05METFORMIN HYDROCHLORIDE500 in 1 BOTTLETABLET5009
50228-105-10METFORMIN HYDROCHLORIDE1000 in 1 BOTTLETABLET10009
50228-105-30METFORMIN HYDROCHLORIDE30 in 1 BOTTLETABLET309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-105-01EA - Each50228-10506030a0e-de92-48ae-b722-161d9bc5219412019-05-02
50228-105-05EA - Each50228-105d8e561c2-73fc-4845-b66e-bd2ad2f1de2112019-05-02
50228-105-10EA - Each50228-10584dd95fa-421a-47ef-8cf0-62b26e4ffc5612019-03-12
50228-105-30EA - Each50228-10562895923-4aa2-43fc-b0b3-81b515f6024e12019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
ACACIAINACTIVE INGREDIENT5C5403N26OMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2METFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6METFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6METFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BMETFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-105METFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]9Current NDC, Legacy NDC, 5 package rows20230110_4e4c4ba9-65c6-4273-8f6b-2423ab521dad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861007metFORMIN HCl 500 MG Oral TabletPSN32d6c5f4-0116-4e38-b179-e1967ae63e66104
861007metformin hydrochloride 500 MG Oral TabletSCD32d6c5f4-0116-4e38-b179-e1967ae63e66104
861007metFORMIN HCl 500 MG Oral TabletPSNa59327bd-a3ba-417b-9e91-4cd3a941e640102
861007metFORMIN HCl 500 MG Oral TabletPSN76879512-3ab4-4acf-92e6-bba0fb75dd0e102
861007metformin hydrochloride 500 MG Oral TabletSCDa59327bd-a3ba-417b-9e91-4cd3a941e640102
861007metformin hydrochloride 500 MG Oral TabletSCD76879512-3ab4-4acf-92e6-bba0fb75dd0e102
861007metFORMIN HCl 500 MG Oral TabletPSNf9e78e0f-6a0a-4db3-bc09-5500748f9c84100
861007metformin hydrochloride 500 MG Oral TabletSCDf9e78e0f-6a0a-4db3-bc09-5500748f9c84100
861004metFORMIN HCl 1000 MG Oral TabletPSNf86bda10-8b25-4125-8bb1-1b5917969ff013
861004metFORMIN HCl 1000 MG Oral TabletPSNc33e24e9-0441-6b94-e053-2a95a90a9c6813
861007metFORMIN HCl 500 MG Oral TabletPSNf86bda10-8b25-4125-8bb1-1b5917969ff013
861007metFORMIN HCl 500 MG Oral TabletPSNc33e24e9-0441-6b94-e053-2a95a90a9c6813
861010metFORMIN HCl 850 MG Oral TabletPSNc33e24e9-0441-6b94-e053-2a95a90a9c6813
861010metFORMIN HCl 850 MG Oral TabletPSNf86bda10-8b25-4125-8bb1-1b5917969ff013
861004metformin hydrochloride 1000 MG Oral TabletSCDf86bda10-8b25-4125-8bb1-1b5917969ff013
861004metformin hydrochloride 1000 MG Oral TabletSCDc33e24e9-0441-6b94-e053-2a95a90a9c6813
861007metformin hydrochloride 500 MG Oral TabletSCDc33e24e9-0441-6b94-e053-2a95a90a9c6813
861007metformin hydrochloride 500 MG Oral TabletSCDf86bda10-8b25-4125-8bb1-1b5917969ff013
861010metformin hydrochloride 850 MG Oral TabletSCDc33e24e9-0441-6b94-e053-2a95a90a9c6813
861010metformin hydrochloride 850 MG Oral TabletSCDf86bda10-8b25-4125-8bb1-1b5917969ff013
861004metformin HCl 1 GM Oral TabletSYc33e24e9-0441-6b94-e053-2a95a90a9c6813
861004metformin HCl 1 GM Oral TabletSYf86bda10-8b25-4125-8bb1-1b5917969ff013
861004metFORMIN HCl 1000 MG Oral TabletPSN4e4c4ba9-65c6-4273-8f6b-2423ab521dad9
861007metFORMIN HCl 500 MG Oral TabletPSN4e4c4ba9-65c6-4273-8f6b-2423ab521dad9
861010metFORMIN HCl 850 MG Oral TabletPSN4e4c4ba9-65c6-4273-8f6b-2423ab521dad9
861004metformin hydrochloride 1000 MG Oral TabletSCD4e4c4ba9-65c6-4273-8f6b-2423ab521dad9
861007metformin hydrochloride 500 MG Oral TabletSCD4e4c4ba9-65c6-4273-8f6b-2423ab521dad9
861010metformin hydrochloride 850 MG Oral TabletSCD4e4c4ba9-65c6-4273-8f6b-2423ab521dad9
861004metformin HCl 1 GM Oral TabletSY4e4c4ba9-65c6-4273-8f6b-2423ab521dad9
861007metFORMIN HCl 500 MG Oral TabletPSN388ee1e0-a0d2-324d-e063-6394a90a16642
861007metformin hydrochloride 500 MG Oral TabletSCD388ee1e0-a0d2-324d-e063-6394a90a16642
861007metFORMIN HCl 500 MG Oral TabletPSNdfac4d9c-2f20-417c-a1be-4f1c2738f3511
861007metFORMIN HCl 500 MG Oral TabletPSNbfdcfcf4-a46b-3f00-e053-2a95a90ab1b61
861007metformin hydrochloride 500 MG Oral TabletSCDdfac4d9c-2f20-417c-a1be-4f1c2738f3511
861007metformin hydrochloride 500 MG Oral TabletSCDbfdcfcf4-a46b-3f00-e053-2a95a90ab1b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-105-00502280105009000 TABLET in 1 BOTTLE (50228-105-00) 9000 tablet2015-02-010000-00-00NoNoCurrent
50228-105-0150228010501100 TABLET in 1 BOTTLE (50228-105-01) 100 tablet2015-02-010000-00-00NoNoCurrent
50228-105-0550228010505500 TABLET in 1 BOTTLE (50228-105-05) 500 tablet2015-02-010000-00-00NoNoCurrent
50228-105-10502280105101000 TABLET in 1 BOTTLE (50228-105-10) 1000 tablet2015-02-010000-00-00NoNoCurrent
50228-105-305022801053030 TABLET in 1 BOTTLE (50228-105-30) 30 tablet2015-02-010000-00-00NoNoCurrent