Methadone Hydrochloride

Product NDC
31722-947
11-digit product format
317220947
Labeler code
31722
Product ID
31722-947_24878a39-232d-45f6-af1f-fbb00eb5d915
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc
Application
ANDA211228
Marketing category
ANDA
Marketing start
2019-01-03
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
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 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
31722-947-01Methadone Hydrochloride100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-947-01EA - Each31722-9479c8114ce-3c83-4706-978c-4e7457532bea12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-947METHADONE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS, INC]6Current NDC, Legacy NDC, 1 package rows20240418_8f4cf84e-165c-489d-a668-0f715053f196.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864706methadone HCl 10 MG Oral TabletPSN8f4cf84e-165c-489d-a668-0f715053f1967
864718methadone HCl 5 MG Oral TabletPSN8f4cf84e-165c-489d-a668-0f715053f1967
864706methadone hydrochloride 10 MG Oral TabletSCD8f4cf84e-165c-489d-a668-0f715053f1967
864718methadone hydrochloride 5 MG Oral TabletSCD8f4cf84e-165c-489d-a668-0f715053f1967

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-947-0131722094701100 TABLET in 1 BOTTLE (31722-947-01) 100 tablet2019-01-030000-00-00NoNoCurrent