Metformin Hydrochloride

Product NDC
0440-5746
11-digit product format
004405746
Labeler code
0440
Product ID
0440-5746_0602af11-dfe8-45b7-991f-5496b08cc0da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA091184
Marketing category
ANDA
Marketing start
2016-03-31
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-5746-00Metformin Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10001
0440-5746-01Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
0440-5746-05Metformin Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5001
0440-5746-81Metformin Hydrochloride300 in 1 BOTTLETABLET, FILM COATED3001
0440-5746-85Metformin Hydrochloride800 in 1 BOTTLETABLET, FILM COATED8001
0440-5746-90Metformin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901
0440-5746-92Metformin Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-5746-00EA - Each0440-57460e903768-b594-4609-9720-542bd1593bf012017-04-05
0440-5746-01EA - Each0440-57467359138e-0710-4947-96a2-5868caf18ca412017-04-05
0440-5746-05EA - Each0440-5746a4b9e266-4037-44bb-83a7-6e3d58f6fdf512017-04-05
0440-5746-81EA - Each0440-574683cc0363-9b75-49ee-991f-67d651eb654212017-04-05
0440-5746-85EA - Each0440-5746a3451816-73c4-4999-b718-f01bb4583f1312017-04-05
0440-5746-90EA - Each0440-5746c27cbb65-80c3-48c0-8629-db57219068ec12017-04-05
0440-5746-92EA - Each0440-57460fe789d4-f38e-4f19-8119-4303831f982212017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-5746METFORMIN HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 7 package rows20160422_2f9c68d0-6fb7-4940-8e4e-f16c413e5b0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN2f9c68d0-6fb7-4940-8e4e-f16c413e5b0c1
861007metFORMIN HCl 500 MG Oral TabletPSN2f9c68d0-6fb7-4940-8e4e-f16c413e5b0c1
861010metFORMIN HCl 850 MG Oral TabletPSN2f9c68d0-6fb7-4940-8e4e-f16c413e5b0c1
861004metformin hydrochloride 1000 MG Oral TabletSCD2f9c68d0-6fb7-4940-8e4e-f16c413e5b0c1
861007metformin hydrochloride 500 MG Oral TabletSCD2f9c68d0-6fb7-4940-8e4e-f16c413e5b0c1
861010metformin hydrochloride 850 MG Oral TabletSCD2f9c68d0-6fb7-4940-8e4e-f16c413e5b0c1
861004metformin HCl 1 GM Oral TabletSY2f9c68d0-6fb7-4940-8e4e-f16c413e5b0c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-5746-00004405746001000 in 1 BOTTLEHistorical
0440-5746-0100440574601100 in 1 BOTTLEHistorical
0440-5746-0500440574605500 in 1 BOTTLEHistorical
0440-5746-8100440574681300 in 1 BOTTLEHistorical
0440-5746-8500440574685800 in 1 BOTTLEHistorical
0440-5746-900044057469090 in 1 BOTTLEHistorical
0440-5746-9200440574692180 in 1 BOTTLEHistorical