FDA.reportPublic FDA data

Methadone Hydrocloride

Product NDC
0527-1927
11-digit product format
005271927
Labeler code
0527
Product ID
0527-1927_127a6533-e403-48b1-9592-5a90d5cf155e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methadone hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
Lannett Company, Inc.
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
2027-12-31
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
2027-12-31

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1927-36Methadone Hydrocloridedye-free, sugar-free, unflavored1 in 1 CARTONCONCENTRATE120
0527-1927-36Methadone Hydrocloridedye-free, sugar-free, unflavored30 mL in 1 BOTTLE, PLASTICCONCENTRATE3020
0527-1927-39Methadone Hydrocloridedye-free, sugar-free, unflavored1000 mL in 1 BOTTLE, PLASTICCONCENTRATE100020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1927METHADONE HYDROCLORIDE DYE-FREE, SUGAR-FREE, UNFLAVORED (METHADONE HYDROCHLORIDE) CONCENTRATE [LANNETT COMPANY, INC.]18Current NDC, Legacy NDC, 3 package rows20241024_0955ea4a-c6b8-431f-ba42-9641b5b102ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSNf9dad5d5-3417-4992-99ee-6550f81add6b106
991147methadone hydrochloride 10 MG/ML Oral SolutionSCDf9dad5d5-3417-4992-99ee-6550f81add6b106
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSYf9dad5d5-3417-4992-99ee-6550f81add6b106
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSYf9dad5d5-3417-4992-99ee-6550f81add6b106
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSN714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe104
991147methadone hydrochloride 10 MG/ML Oral SolutionSCD714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe104
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSY714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe104
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSY714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe104
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSN0955ea4a-c6b8-431f-ba42-9641b5b102ea20
991147methadone hydrochloride 10 MG/ML Oral SolutionSCD0955ea4a-c6b8-431f-ba42-9641b5b102ea20
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSY0955ea4a-c6b8-431f-ba42-9641b5b102ea20
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSY0955ea4a-c6b8-431f-ba42-9641b5b102ea20
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSNf7dceff7-dfa2-4914-a312-42028492096c2
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSN29079045-112f-4f60-992e-fb24116c06712
991147methadone hydrochloride 10 MG/ML Oral SolutionSCDf7dceff7-dfa2-4914-a312-42028492096c2
991147methadone hydrochloride 10 MG/ML Oral SolutionSCD29079045-112f-4f60-992e-fb24116c06712
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSY29079045-112f-4f60-992e-fb24116c06712
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSYf7dceff7-dfa2-4914-a312-42028492096c2
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSY29079045-112f-4f60-992e-fb24116c06712
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSYf7dceff7-dfa2-4914-a312-42028492096c2
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
0527-1927-36005271927361 BOTTLE, PLASTIC in 1 CARTON (0527-1927-36) / 30 mL in 1 BOTTLE, PLASTIC2020-11-020000-00-00NoNoCurrent
0527-1927-39005271927391000 mL in 1 BOTTLE, PLASTIC (0527-1927-39) 1000 ml2020-11-020000-00-00NoNoCurrent