Methadone Hydrocloride

Product NDC
17856-1927
11-digit product format
178561927
Labeler code
17856
Product ID
17856-1927_373c6844-095b-a726-e063-6294a90a2544
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methadone hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
Atlantic Biologicals Corp.
Application
ANDA212093
Marketing category
ANDA
Marketing start
2020-11-02
Substance
METHADONE HYDROCHLORIDE
Active strength
10 mg/mL
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 Hydrocloride
Brand name suffix
dye-free, sugar-free, unflavored
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHADONE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii229809935B
Rxcui991147

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc6c52c8-e3e2-9042-21d0-6770dcf1a49bProduct name320250819
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a48f0261-b6cc-12b3-49fd-ed131bc5aa96Product name420210902
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9Product name620200708
a6a96832-f31d-b458-45cb-abb8bd940b44Product name220200304
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1927-7Methadone Hydrocloridedye-free, sugar-free, unflavored1 in 1 BAGCONCENTRATE11
17856-1927-7Methadone Hydrocloridedye-free, sugar-free, unflavored0.5 mL in 1 SYRINGECONCENTRATE0.51
17856-1927-8Methadone Hydrocloridedye-free, sugar-free, unflavored1 in 1 BAGCONCENTRATE11
17856-1927-8Methadone Hydrocloridedye-free, sugar-free, unflavored1 mL in 1 SYRINGECONCENTRATE11
17856-1927-9Methadone Hydrocloridedye-free, sugar-free, unflavored2.5 mL in 1 SYRINGECONCENTRATE2.51
17856-1927-9Methadone Hydrocloridedye-free, sugar-free, unflavored1 in 1 BAGCONCENTRATE11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSN373c649e-798d-770e-e063-6294a90a6e471
991147methadone hydrochloride 10 MG/ML Oral SolutionSCD373c649e-798d-770e-e063-6294a90a6e471
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSY373c649e-798d-770e-e063-6294a90a6e471
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSY373c649e-798d-770e-e063-6294a90a6e471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-1927-11785619270160 SYRINGE in 1 BOX, UNIT-DOSE (17856-1927-1) > 1 mL in 1 SYRINGE60 syringe2021-05-120000-00-00NoNoCurrent
17856-1927-21785619270272 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-1927-2) > 5 mL in 1 CUP, UNIT-DOSE2021-06-160000-00-00NoNoCurrent
17856-1927-31785619270360 SYRINGE in 1 BOX, UNIT-DOSE (17856-1927-3) > .5 mL in 1 SYRINGE60 syringe2021-06-160000-00-00NoNoCurrent
17856-1927-417856192704120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1927-4) > .5 mL in 1 SYRINGE120 syringe2021-06-160000-00-00NoNoCurrent
17856-1927-51785619270572 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-1927-5) > 2.5 mL in 1 CUP, UNIT-DOSE2021-06-160000-00-00NoNoCurrent
17856-1927-61785619270660 SYRINGE in 1 BOX (17856-1927-6) > .25 mL in 1 SYRINGE60 syringe2022-04-200000-00-00NoNoCurrent
17856-1927-7178561927071 SYRINGE in 1 BAG (17856-1927-7) / .5 mL in 1 SYRINGE1 syringe2025-05-29NoNoCurrent
17856-1927-8178561927081 SYRINGE in 1 BAG (17856-1927-8) / 1 mL in 1 SYRINGE1 syringe2025-05-29NoNoCurrent
17856-1927-9178561927091 SYRINGE in 1 BAG (17856-1927-9) / 2.5 mL in 1 SYRINGE1 syringe2025-05-29NoNoCurrent