FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
69367-383
11-digit product format
693670383
Labeler code
69367
Product ID
69367-383_982c2026-cf0f-449e-9576-2548af623c35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA205096
Marketing category
ANDA
Marketing start
2024-03-04
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-383-01Metformin Hydrochloride100 in 1 BOTTLETABLET, COATED1002
69367-383-05Metformin Hydrochloride500 in 1 BOTTLETABLET, COATED5002
69367-383-10Metformin Hydrochloride1000 in 1 BOTTLETABLET, COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-383-01EA - Each69367-3831b2c50c5-11b5-400a-be0d-e49afabbcc3e12024-05-16
69367-383-05EA - Each69367-38307cf4994-7a5c-47d4-ae94-aff0cf0f395812024-05-16
69367-383-10EA - Each69367-3838353393d-7e37-455b-9874-968dd6b629af12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-383METFORMIN HYDROCHLORIDE TABLET, COATED [WESTMINSTER PHARMACEUTICALS, LLC]2Current NDC, 3 package rows20240905_583dac53-65e7-4710-912a-ecd89d07ad03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSNf6581ce6-0f9f-4887-ae83-4c6ecde619f32
861004metFORMIN HCl 1000 MG Oral TabletPSN583dac53-65e7-4710-912a-ecd89d07ad032
861007metFORMIN HCl 500 MG Oral TabletPSN583dac53-65e7-4710-912a-ecd89d07ad032
861010metFORMIN HCl 850 MG Oral TabletPSN583dac53-65e7-4710-912a-ecd89d07ad032
861004metformin hydrochloride 1000 MG Oral TabletSCDf6581ce6-0f9f-4887-ae83-4c6ecde619f32
861004metformin hydrochloride 1000 MG Oral TabletSCD583dac53-65e7-4710-912a-ecd89d07ad032
861007metformin hydrochloride 500 MG Oral TabletSCD583dac53-65e7-4710-912a-ecd89d07ad032
861010metformin hydrochloride 850 MG Oral TabletSCD583dac53-65e7-4710-912a-ecd89d07ad032
861004metformin HCl 1 GM Oral TabletSYf6581ce6-0f9f-4887-ae83-4c6ecde619f32
861004metformin HCl 1 GM Oral TabletSY583dac53-65e7-4710-912a-ecd89d07ad032
861004metFORMIN HCl 1000 MG Oral TabletPSN32ff33ed-89ed-c391-e063-6294a90ae4141
861004metFORMIN HCl 1000 MG Oral TabletPSN4d4021ba-4b28-6b81-e063-6294a90a5ea71
861004metFORMIN HCl 1000 MG Oral TabletPSN565610b8-a9a0-4e5e-866d-81d9501a817d1
861004metFORMIN HCl 1000 MG Oral TabletPSN2d2ebf52-3d5e-4fad-b7f7-c9280957574c1
861004metformin hydrochloride 1000 MG Oral TabletSCD565610b8-a9a0-4e5e-866d-81d9501a817d1
861004metformin hydrochloride 1000 MG Oral TabletSCD4d4021ba-4b28-6b81-e063-6294a90a5ea71
861004metformin hydrochloride 1000 MG Oral TabletSCD32ff33ed-89ed-c391-e063-6294a90ae4141
861004metformin hydrochloride 1000 MG Oral TabletSCD2d2ebf52-3d5e-4fad-b7f7-c9280957574c1
861004metformin HCl 1 GM Oral TabletSY565610b8-a9a0-4e5e-866d-81d9501a817d1
861004metformin HCl 1 GM Oral TabletSY4d4021ba-4b28-6b81-e063-6294a90a5ea71
861004metformin HCl 1 GM Oral TabletSY32ff33ed-89ed-c391-e063-6294a90ae4141
861004metformin HCl 1 GM Oral TabletSY2d2ebf52-3d5e-4fad-b7f7-c9280957574c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-383-0169367038301100 TABLET, COATED in 1 BOTTLE (69367-383-01) 2024-03-04NoNoCurrent
69367-383-0569367038305500 TABLET, COATED in 1 BOTTLE (69367-383-05) 2024-03-04NoNoCurrent
69367-383-10693670383101000 TABLET, COATED in 1 BOTTLE (69367-383-10) 2024-03-04NoNoCurrent