FDA.reportPublic FDA data

Methadone Hydrochloride

Product NDC
68094-031
11-digit product format
680940031
Labeler code
68094
Product ID
68094-031_b9e6a3ca-9559-4dfa-b742-646be5def826
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA087393
Marketing category
ANDA
Marketing start
2020-12-23
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
68094-031-59Methadone Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION55
68094-031-62Methadone Hydrochloride3 in 1 CASESOLUTION35
68094-031-62Methadone Hydrochloride10 in 1 TRAYSOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-031-59ML - Milliliter68094-0318e9c7997-5540-4e74-9109-5e1d9f59156a12021-01-08
68094-031-62ML - Milliliter68094-0310b1f1f24-d1bc-413c-be19-34625eeab42812021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-031METHADONE HYDROCHLORIDE SOLUTION [PRECISION DOSE, INC.]4Current NDC, Legacy NDC, 3 package rows20250305_cbc42334-8783-4572-b8da-8c7451d14077.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864761methadone HCl 5 MG in 5 mL Oral SolutionPSNcbc42334-8783-4572-b8da-8c7451d140775
864761methadone hydrochloride 1 MG/ML Oral SolutionSCDcbc42334-8783-4572-b8da-8c7451d140775
864761methadone HCl 5 MG per 5 ML Oral SolutionSYcbc42334-8783-4572-b8da-8c7451d140775

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-031-59680940031595 mL in 1 CUP, UNIT-DOSE5 mlHistorical
68094-031-62680940031623 TRAY in 1 CASE (68094-031-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-031-59) 3 tray2020-12-230000-00-00NoNoCurrent