FDA.reportPublic FDA data

Methadone Hydrochloride

Product NDC
68094-331
11-digit product format
680940331
Labeler code
68094
Product ID
68094-331_f323b0eb-5527-4874-aee6-ef6f49e5784b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA087393
Marketing category
ANDA
Marketing start
2023-12-29
Substance
METHADONE HYDROCHLORIDE
Active strength
5 mg/5mL
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 HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii229809935B
Rxcui864761

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc6c52c8-e3e2-9042-21d0-6770dcf1a49bProduct name320250819
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
a48f0261-b6cc-12b3-49fd-ed131bc5aa96Product name420210902
00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9Product name620200708
a6a96832-f31d-b458-45cb-abb8bd940b44Product name220200304
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-331-01Methadone Hydrochloride1 mL in 1 SYRINGE, PLASTICSOLUTION12
68094-331-58Methadone Hydrochloride1 in 1 BAGSOLUTION12
68094-331-58Methadone Hydrochloride50 in 1 CASESOLUTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-331METHADONE HYDROCHLORIDE SOLUTION [PRECISION DOSE, INC.]2Current NDC, 3 package rows20250110_e980d666-d74d-4358-a3b7-c6accb15eba6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864761methadone HCl 5 MG in 5 mL Oral SolutionPSNe980d666-d74d-4358-a3b7-c6accb15eba62
864761methadone hydrochloride 1 MG/ML Oral SolutionSCDe980d666-d74d-4358-a3b7-c6accb15eba62
864761methadone HCl 5 MG per 5 ML Oral SolutionSYe980d666-d74d-4358-a3b7-c6accb15eba62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68094-331-01680940331011 mL in 1 SYRINGE, PLASTIC1 mlHistorical
68094-331-586809403315850 BAG in 1 CASE (68094-331-58) / 1 SYRINGE, PLASTIC in 1 BAG / 1 mL in 1 SYRINGE, PLASTIC (68094-331-01) 50 bag2023-12-29NoNoHistorical