FDA.reportPublic FDA data

DISKETS

Product NDC
0054-4538
11-digit product format
000544538
Labeler code
0054
Product ID
0054-4538_5d09b929-38f0-4c89-8bf5-31427a5cd393
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA017058
Marketing category
NDA
Marketing start
1973-03-14
Substance
METHADONE HYDROCHLORIDE
Active strength
40 mg/1
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
DISKETS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHADONE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii229809935B
Rxcui864978, 1990745

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc6c52c8-e3e2-9042-21d0-6770dcf1a49bProduct name320250819
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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
0054-4538-25DISKETS100 in 1 BOTTLE, PLASTICTABLET10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-4538-25EA - Each0054-4538fd70ce12-6fc2-4c2a-b167-db3d823bc95812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BDISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]5
METHADONEACTIVE MOIETYUC6VBE7V1ZDISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]5
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51DISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-4538DISKETS (METHADONE HYDROCHLORIDE) TABLET [HIKMA PHARMACEUTICALS USA INC.]15Current NDC, Legacy NDC, 1 package rows20240215_e6af84de-cbfc-4a3b-bd73-6bcf77337168.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1990745DISKETS 40 MG Tablet for Oral SuspensionPSNe6af84de-cbfc-4a3b-bd73-6bcf7733716819
864978methadone HCl 40 MG Tablet for Oral SuspensionPSNe6af84de-cbfc-4a3b-bd73-6bcf7733716819
1990745methadone hydrochloride 40 MG Tablet for Oral Suspension [Diskets]SBDe6af84de-cbfc-4a3b-bd73-6bcf7733716819
864978methadone hydrochloride 40 MG Tablet for Oral SuspensionSCDe6af84de-cbfc-4a3b-bd73-6bcf7733716819
1990745Diskets 40 MG Tablet for Oral SuspensionSYe6af84de-cbfc-4a3b-bd73-6bcf7733716819
864978methadone HCl 40 MG Tablet for Oral SuspensionSYe6af84de-cbfc-4a3b-bd73-6bcf7733716819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-4538-2500054453825100 TABLET in 1 BOTTLE, PLASTIC (0054-4538-25) 100 tablet1973-03-140000-00-00NoNoCurrent