FDA.reportPublic FDA data

METHADONE HYDROCHLORIDE

Product NDC
0054-0710
11-digit product format
000540710
Labeler code
0054
Product ID
0054-0710_32014633-5c89-4163-9fa7-239777c04d1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHADONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA088109
Marketing category
ANDA
Marketing start
1983-03-08
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
METHADONE HYDROCHLORIDE
Listing expiration
2027-12-31

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
0054-0710-20METHADONE HYDROCHLORIDE100 in 1 BLISTER PACKTABLET1009
0054-0710-20METHADONE HYDROCHLORIDE1 in 1 CARTONTABLET19
0054-0710-25METHADONE HYDROCHLORIDE100 in 1 BOTTLE, PLASTICTABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0710-20EA - Each0054-0710dbc17ec6-6148-4c26-8784-2d11316fb02712021-02-05
0054-0710-25EA - Each0054-071074f615cc-ef24-4845-adf3-4701d95c622512021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0710METHADONE HYDROCHLORIDE TABLET [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 3 package rows20250202_50f14803-78c0-4d19-8b5d-9a9c17582ac1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864706methadone HCl 10 MG Oral TabletPSN50f14803-78c0-4d19-8b5d-9a9c17582ac19
864718methadone HCl 5 MG Oral TabletPSN50f14803-78c0-4d19-8b5d-9a9c17582ac19
864706methadone hydrochloride 10 MG Oral TabletSCD50f14803-78c0-4d19-8b5d-9a9c17582ac19
864718methadone hydrochloride 5 MG Oral TabletSCD50f14803-78c0-4d19-8b5d-9a9c17582ac19
864706methadone HCl 10 MG Oral TabletPSNdb52fdc0-765a-4fad-a8f9-ef98c6e4b8984
864706methadone hydrochloride 10 MG Oral TabletSCDdb52fdc0-765a-4fad-a8f9-ef98c6e4b8984

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0710-20000540710201 BLISTER PACK in 1 CARTON (0054-0710-20) / 100 TABLET in 1 BLISTER PACK1 blister pack1983-03-080000-00-00NoNoCurrent
0054-0710-2500054071025100 TABLET in 1 BOTTLE, PLASTIC (0054-0710-25) 100 tablet1983-03-080000-00-00NoNoCurrent