Metformin Hydrochloride

Product NDC
33261-372
11-digit product format
332610372
Labeler code
33261
Product ID
33261-372_7051a1a4-226c-4a41-b5d3-0f666740855b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078596
Marketing category
ANDA
Marketing start
2009-12-02
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
33261-372-02Metformin Hydrochloride120 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1202
33261-372-30Metformin Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE302
33261-372-60Metformin Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-372-02EA - Each33261-372bade189d-160b-4d49-ab2e-8fde8d36090812016-09-02
33261-372-30EA - Each33261-3727de2059c-ec94-4abd-aadf-cf671f90de4312015-10-02
33261-372-60EA - Each33261-372b14ff0d9-0456-4a47-82ad-e8942920075912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-372METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 3 package rows20140128_4b163d1c-0bd6-4002-a954-b1b2cc8325bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN4b163d1c-0bd6-4002-a954-b1b2cc8325bc2
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD4b163d1c-0bd6-4002-a954-b1b2cc8325bc2
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY4b163d1c-0bd6-4002-a954-b1b2cc8325bc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-372-0233261037202120 in 1 BOTTLE, PLASTICHistorical
33261-372-303326103723030 in 1 BOTTLE, PLASTICHistorical
33261-372-603326103726060 in 1 BOTTLE, PLASTICHistorical