FDA.reportPublic FDA data

METHADONE HYDROCHLORIDE

Product NDC
71335-1360
11-digit product format
713351360
Labeler code
71335
Product ID
71335-1360_6f29db41-72f8-4eee-b826-d095449170f8
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
71335-1360-0METHADONE HYDROCHLORIDE168 in 1 BOTTLETABLET1684
71335-1360-1METHADONE HYDROCHLORIDE15 in 1 BOTTLETABLET154
71335-1360-2METHADONE HYDROCHLORIDE30 in 1 BOTTLETABLET304
71335-1360-3METHADONE HYDROCHLORIDE90 in 1 BOTTLETABLET904
71335-1360-4METHADONE HYDROCHLORIDE120 in 1 BOTTLETABLET1204
71335-1360-5METHADONE HYDROCHLORIDE180 in 1 BOTTLETABLET1804
71335-1360-6METHADONE HYDROCHLORIDE60 in 1 BOTTLETABLET604
71335-1360-7METHADONE HYDROCHLORIDE28 in 1 BOTTLETABLET284
71335-1360-8METHADONE HYDROCHLORIDE112 in 1 BOTTLETABLET1124
71335-1360-9METHADONE HYDROCHLORIDE56 in 1 BOTTLETABLET564

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1360-3EA - Each71335-136079fed854-46f3-4fbf-81d3-5fa05d33620312022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1360METHADONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 10 package rows20231107_7a8635fe-6183-4cda-9029-50e4e6dd5832.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864706methadone HCl 10 MG Oral TabletPSN7a8635fe-6183-4cda-9029-50e4e6dd58324
864706methadone hydrochloride 10 MG Oral TabletSCD7a8635fe-6183-4cda-9029-50e4e6dd58324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1360-071335136000168 TABLET in 1 BOTTLE (71335-1360-0) 168 tablet2022-09-280000-00-00NoNoCurrent
71335-1360-17133513600115 TABLET in 1 BOTTLE (71335-1360-1) 15 tablet2022-09-280000-00-00NoNoCurrent
71335-1360-27133513600230 TABLET in 1 BOTTLE (71335-1360-2) 30 tablet2019-10-010000-00-00NoNoCurrent
71335-1360-37133513600390 TABLET in 1 BOTTLE (71335-1360-3) 90 tablet2020-08-140000-00-00NoNoCurrent
71335-1360-471335136004120 TABLET in 1 BOTTLE (71335-1360-4) 120 tablet2022-09-280000-00-00NoNoCurrent
71335-1360-571335136005180 TABLET in 1 BOTTLE (71335-1360-5) 180 tablet2022-09-280000-00-00NoNoCurrent
71335-1360-67133513600660 TABLET in 1 BOTTLE (71335-1360-6) 60 tablet2022-09-280000-00-00NoNoCurrent
71335-1360-77133513600728 TABLET in 1 BOTTLE (71335-1360-7) 28 tablet2022-09-280000-00-00NoNoCurrent
71335-1360-871335136008112 TABLET in 1 BOTTLE (71335-1360-8) 112 tablet2022-09-280000-00-00NoNoCurrent
71335-1360-97133513600956 TABLET in 1 BOTTLE (71335-1360-9) 56 tablet2022-09-280000-00-00NoNoCurrent