FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
47335-306
11-digit product format
473350306
Labeler code
47335
Product ID
47335-306_33ab529d-b535-4138-9c3d-dbde05d702c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA202917
Marketing category
ANDA
Marketing start
2018-05-22
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 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 HYDROCHLORIDE1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui1807888, 1807915

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
47335-306-18Metformin Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100011
47335-306-81Metformin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9011
47335-306-83Metformin Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3011
47335-306-88Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-306-88EA - Each47335-3066f64aee9-3ed3-4fc5-96e3-c9e8bccfd48312018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-306METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]11Current NDC, Legacy NDC, 4 package rows20240112_52c18b5c-2322-4b22-a36e-3c573d609dd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807888metFORMIN HCl 1000 MG Modified 24HR Extended Release Oral TabletPSN52c18b5c-2322-4b22-a36e-3c573d609dd011
1807915metFORMIN HCl 500 MG Modified 24HR Extended Release Oral TabletPSN52c18b5c-2322-4b22-a36e-3c573d609dd011
1807888Modified 24 HR metformin hydrochloride 1000 MG Extended Release Oral TabletSCD52c18b5c-2322-4b22-a36e-3c573d609dd011
1807915Modified 24 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD52c18b5c-2322-4b22-a36e-3c573d609dd011
1807888metformin HCl 1000 MG Modified 24 HR Extended Release Oral TabletSY52c18b5c-2322-4b22-a36e-3c573d609dd011
1807915metformin HCl 500 MG Modified 24 HR Extended Release Oral TabletSY52c18b5c-2322-4b22-a36e-3c573d609dd011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-306-18473350306181000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-18) 2018-05-220000-00-00NoNoCurrent
47335-306-814733503068190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-81) 2019-07-220000-00-00NoNoCurrent
47335-306-834733503068330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-83) 2018-05-220000-00-00NoNoCurrent
47335-306-8847335030688100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-88) 2018-05-220000-00-00NoNoCurrent