FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
67877-159
11-digit product format
678770159
Labeler code
67877
Product ID
67877-159_52665dfa-e57e-823b-e063-6294a90a74b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA201991
Marketing category
ANDA
Marketing start
2013-03-01
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 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 HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E

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
67877-159-01METFORMIN HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
67877-159-05METFORMIN HYDROCHLORIDE500 in 1 BOTTLETABLET, EXTENDED RELEASE5009
67877-159-10METFORMIN HYDROCHLORIDE1000 in 1 BOTTLETABLET, EXTENDED RELEASE10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-159-01EA - Each67877-1590f49d07c-02d4-404e-b49c-920880c765a712013-06-04
67877-159-05EA - Each67877-159eaadf8a4-b0c2-4c66-a746-034d0d1a64fe12013-06-04
67877-159-10EA - Each67877-1594b4c7393-c039-4d27-9531-0e0beaa2178912013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]2
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-159METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]5Current NDC, Legacy NDC, 3 package rows20210108_a944a167-e3ac-4084-af1c-22b48713471c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN88f1fd59-6906-9755-e053-2a95a90acc6116
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD88f1fd59-6906-9755-e053-2a95a90acc6116
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY88f1fd59-6906-9755-e053-2a95a90acc6116
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN0cd086d6-3ae2-476e-b93e-29055e67e8fc15
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD0cd086d6-3ae2-476e-b93e-29055e67e8fc15
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY0cd086d6-3ae2-476e-b93e-29055e67e8fc15
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN9171d369-d35a-40e4-a9ad-26484e66fc5e14
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD9171d369-d35a-40e4-a9ad-26484e66fc5e14
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY9171d369-d35a-40e4-a9ad-26484e66fc5e14
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNa944a167-e3ac-4084-af1c-22b48713471c9
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDa944a167-e3ac-4084-af1c-22b48713471c9
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYa944a167-e3ac-4084-af1c-22b48713471c9
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN5bb945c1-954a-4d43-aa24-33767d19c57c7
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNf55a245b-a786-4a4a-b11c-c61d48294b017
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD5bb945c1-954a-4d43-aa24-33767d19c57c7
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDf55a245b-a786-4a4a-b11c-c61d48294b017
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYf55a245b-a786-4a4a-b11c-c61d48294b017
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY5bb945c1-954a-4d43-aa24-33767d19c57c7
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN3ba957ea-28ed-4a61-a318-98064ea4944d6
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD3ba957ea-28ed-4a61-a318-98064ea4944d6
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY3ba957ea-28ed-4a61-a318-98064ea4944d6
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNf2318509-9a49-4c99-a08b-22381f17aacd5
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDf2318509-9a49-4c99-a08b-22381f17aacd5
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYf2318509-9a49-4c99-a08b-22381f17aacd5
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN07d8a69f-30d9-7511-e063-6394a90a95ca3
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNa434b937-2648-4509-8ce8-94a28582ec773
1807917metFORMIN HCl 500 MG Osmotic 24HR Extended Release Oral TabletPSN4be72741-4f6d-6689-e054-00144ff8d46c3
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD07d8a69f-30d9-7511-e063-6394a90a95ca3
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDa434b937-2648-4509-8ce8-94a28582ec773
1807917Osmotic 24 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD4be72741-4f6d-6689-e054-00144ff8d46c3
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYa434b937-2648-4509-8ce8-94a28582ec773
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY07d8a69f-30d9-7511-e063-6394a90a95ca3
1807917metformin HCl 500 MG Osmotic 24HR Extended Release Oral TabletSY4be72741-4f6d-6689-e054-00144ff8d46c3
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN1ea02753-c9d0-3b4c-e054-00144ff8d46c2
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD1ea02753-c9d0-3b4c-e054-00144ff8d46c2
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY1ea02753-c9d0-3b4c-e054-00144ff8d46c2
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN784a6bbd-4f13-45ed-89c1-154b06721ed01
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN4adeddf2-f449-4a61-9658-dfbff7c502301
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN1a047fc0-196e-79af-e063-6394a90a1e0d1
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD784a6bbd-4f13-45ed-89c1-154b06721ed01
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD1a047fc0-196e-79af-e063-6394a90a1e0d1
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD4adeddf2-f449-4a61-9658-dfbff7c502301
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY4adeddf2-f449-4a61-9658-dfbff7c502301
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY784a6bbd-4f13-45ed-89c1-154b06721ed01
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY1a047fc0-196e-79af-e063-6394a90a1e0d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-159-0167877015901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-159-01) 2016-11-250000-00-00NoNoCurrent
67877-159-0567877015905500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-159-05) 2016-11-250000-00-00NoNoCurrent
67877-159-10678770159101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-159-10) 2016-11-250000-00-00NoNoCurrent