FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
21695-473
11-digit product format
216950473
Labeler code
21695
Product ID
21695-473_495738b9-2511-446b-833c-164c0119035b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA075967
Marketing category
ANDA
Marketing start
2002-01-29
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
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-473-302019-09-24C16284748780-1934fe258-4a01-48b1-e053-8cdaa90a720aMETFORMIN HYDROCHLORIDE
21695-473-602019-09-24C16284748780-1934fe258-4a01-48b1-e053-8cdaa90a720aMETFORMIN HYDROCHLORIDE
21695-473-782019-09-24C16284748780-1934fe258-4a01-48b1-e053-8cdaa90a720aMETFORMIN HYDROCHLORIDE
21695-473-902019-09-24C16284748780-1934fe258-4a01-48b1-e053-8cdaa90a720aMETFORMIN HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-473-30METFORMIN HYDROCHLORIDE30 in 1 BOTTLETABLET301
21695-473-60METFORMIN HYDROCHLORIDE60 in 1 BOTTLETABLET601
21695-473-78METFORMIN HYDROCHLORIDE180 in 1 BOTTLETABLET1801
21695-473-90METFORMIN HYDROCHLORIDE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-473-30EA - Each21695-473e9f3c813-81a5-489a-bcf2-e1261240bfde12012-07-24
21695-473-60EA - Each21695-473fdfa8d11-a44e-4476-8e17-9f34c29e071812013-02-13
21695-473-78EA - Each21695-4733bea3888-14cd-4c0c-b171-a4b3a036405412012-07-24
21695-473-90EA - Each21695-47399dfe40c-1fed-459a-9d0b-26965f382e5f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMETFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-473METFORMIN HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 4 package rows20110923_495738b9-2511-446b-833c-164c0119035b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN495738b9-2511-446b-833c-164c0119035b1
861007metFORMIN HCl 500 MG Oral TabletPSN495738b9-2511-446b-833c-164c0119035b1
861010metFORMIN HCl 850 MG Oral TabletPSN495738b9-2511-446b-833c-164c0119035b1
861004metformin hydrochloride 1000 MG Oral TabletSCD495738b9-2511-446b-833c-164c0119035b1
861007metformin hydrochloride 500 MG Oral TabletSCD495738b9-2511-446b-833c-164c0119035b1
861010metformin hydrochloride 850 MG Oral TabletSCD495738b9-2511-446b-833c-164c0119035b1
861004metformin HCl 1 GM Oral TabletSY495738b9-2511-446b-833c-164c0119035b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-473-302169504733030 in 1 BOTTLEHistorical
21695-473-602169504736060 in 1 BOTTLEHistorical
21695-473-7821695047378180 in 1 BOTTLEHistorical
21695-473-902169504739090 in 1 BOTTLEHistorical