METHADONE HYDROCHLORIDE

Product NDC
63629-1027
11-digit product format
636291027
Labeler code
63629
Product ID
63629-1027_c513c20b-ef58-4df1-8cce-ab397ef8e67c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHADONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090635
Marketing category
ANDA
Marketing start
2012-01-16
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

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
63629-1027-1METHADONE HYDROCHLORIDE100 in 1 BOTTLETABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1027-1EA - Each63629-10276f28868c-f31a-41a9-b06e-6c18e951bb4712019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1027METHADONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 1 package rows20230127_3ce98ab4-346b-4680-b3e1-a8c29b3933af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864706methadone HCl 10 MG Oral TabletPSN3ce98ab4-346b-4680-b3e1-a8c29b3933af10
864706methadone hydrochloride 10 MG Oral TabletSCD3ce98ab4-346b-4680-b3e1-a8c29b3933af10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1027-163629102701100 TABLET in 1 BOTTLE (63629-1027-1) 100 tablet2020-01-160000-00-00NoNoCurrent