Methadone Hydrochloride
- Product NDC
- 0054-0392
- 11-digit product format
- 000540392
- Labeler code
- 0054
- Product ID
- 0054-0392_6cc1b9b7-bfbc-478b-a572-05a802018bda
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methadone Hydrochloride
- Dosage form
- CONCENTRATE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA
- Application
- ANDA040180
- Marketing category
- ANDA
- Marketing start
- 2010-03-16
- 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 Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHADONE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 229809935B |
| Rxcui | 991147 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0392-68 | Methadone Hydrochloride | 1000 mL in 1 BOTTLE | CONCENTRATE | 1000 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METHADONE HYDROCHLORIDE | ACTIVE INGREDIENT | 229809935B | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 7 | |
| METHADONE | ACTIVE MOIETY | UC6VBE7V1Z | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 7 | |
| CHERRY | INACTIVE INGREDIENT | BUC5I9595W | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 7 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 7 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 7 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 7 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 7 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 7 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 7 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 7 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 7 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0392 | METHADONE HYDROCHLORIDE CONCENTRATE [HIKMA PHARMACEUTICALS USA] | 17 | Current NDC, Legacy NDC, 1 package rows | 20240601_e72841bf-364b-49b1-8e69-7e26ddcd2657.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0392-68 | 00054039268 | 1000 mL in 1 BOTTLE (0054-0392-68) | 1000 ml | 2010-03-16 | 0000-00-00 | No | No | Current |