FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
68094-804
11-digit product format
680940804
Labeler code
68094
Product ID
68094-804_6dc13e06-f6e2-4478-9981-212f5ae23b4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA078321
Marketing category
ANDA
Marketing start
2024-02-15
Substance
METFORMIN HYDROCHLORIDE
Active strength
750 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metformin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui860975, 860981

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
68094-804-50Metformin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
68094-804-60Metformin Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-804-50EA - Each68094-804310b7dab-86ec-45d8-aed8-c99e6230bd4312024-07-12
68094-804-60EA - Each68094-804122010a5-8acf-42f3-a293-486ffe30d2bc12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-804METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PRECISION DOSE, INC.]1Current NDC, 2 package rows20240215_60142fb2-16da-4f54-a542-74f9a70b9c8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSNde09f7a1-1e9f-60f4-e053-2a95a90a93d86
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCDde09f7a1-1e9f-60f4-e053-2a95a90a93d86
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSYde09f7a1-1e9f-60f4-e053-2a95a90a93d86
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN60142fb2-16da-4f54-a542-74f9a70b9c8b5
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN60142fb2-16da-4f54-a542-74f9a70b9c8b5
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD60142fb2-16da-4f54-a542-74f9a70b9c8b5
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD60142fb2-16da-4f54-a542-74f9a70b9c8b5
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY60142fb2-16da-4f54-a542-74f9a70b9c8b5
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY60142fb2-16da-4f54-a542-74f9a70b9c8b5
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN41408f64-d366-403e-9595-464ab25c6f974
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD41408f64-d366-403e-9595-464ab25c6f974
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY41408f64-d366-403e-9595-464ab25c6f974
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSNc568d49f-c040-4f1e-ad36-77b05ab659c33
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCDc568d49f-c040-4f1e-ad36-77b05ab659c33
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSYc568d49f-c040-4f1e-ad36-77b05ab659c33
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN4d245bc3-0add-4651-b441-86b93c5ac6812
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD4d245bc3-0add-4651-b441-86b93c5ac6812
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY4d245bc3-0add-4651-b441-86b93c5ac6812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68094-804-5068094080450100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68094-804-50) 2024-02-15NoNoCurrent
68094-804-6068094080460500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68094-804-60) 2024-02-15NoNoCurrent