FDA.reportPublic FDA data

Methadone Hydrochloride

Product NDC
13107-089
11-digit product format
131070089
Labeler code
13107
Product ID
13107-089_73006026-6ba2-49da-824e-a4d05b99a2e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA203502
Marketing category
ANDA
Marketing start
2015-09-15
Substance
METHADONE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methadone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHADONE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii229809935B
Rxcui864706, 864718

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc6c52c8-e3e2-9042-21d0-6770dcf1a49bProduct name320250819
a48f0261-b6cc-12b3-49fd-ed131bc5aa96Product name420210902
00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9Product name620200708
a6a96832-f31d-b458-45cb-abb8bd940b44Product name220200304

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-089-01Methadone Hydrochloride100 in 1 BOTTLETABLET10018
13107-089-30Methadone Hydrochloride30 in 1 BOTTLETABLET3018
13107-089-99Methadone Hydrochloride1000 in 1 BOTTLETABLET100018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-089-01EA - Each13107-08960c11f71-bd5d-4ae1-a410-4d38a639659412016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]3
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-089METHADONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]16Current NDC, Legacy NDC, 3 package rows20240704_6984eb5a-57a3-4686-bc67-91bc3e7a531e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864706methadone HCl 10 MG Oral TabletPSN6984eb5a-57a3-4686-bc67-91bc3e7a531e18
864718methadone HCl 5 MG Oral TabletPSN6984eb5a-57a3-4686-bc67-91bc3e7a531e18
864706methadone hydrochloride 10 MG Oral TabletSCD6984eb5a-57a3-4686-bc67-91bc3e7a531e18
864718methadone hydrochloride 5 MG Oral TabletSCD6984eb5a-57a3-4686-bc67-91bc3e7a531e18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-089-0113107008901100 TABLET in 1 BOTTLE (13107-089-01) 100 tablet2015-09-150000-00-00NoNoCurrent
13107-089-301310700893030 TABLET in 1 BOTTLE (13107-089-30) 30 tablet2015-09-150000-00-00NoNoCurrent
13107-089-99131070089991000 TABLET in 1 BOTTLE (13107-089-99) 1000 tablet2015-09-150000-00-00NoNoCurrent