Methadone Hydrochloride
- Product NDC
- 67457-217
- 11-digit product format
- 674570217
- Labeler code
- 67457
- Product ID
- 67457-217_868dd5b8-2e28-475c-b6c3-bfc0a33fb793
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methadone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Mylan Institutional LLC
- Application
- NDA021624
- Marketing category
- NDA
- Marketing start
- 2012-12-20
- 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 Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHADONE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 229809935B |
| Rxcui | 864714 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-217-20 | Methadone Hydrochloride | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 16 |
| 67457-217-20 | Methadone Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 16 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-217 | METHADONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 15 | Current NDC, Legacy NDC, 2 package rows | 20240430_092d78eb-6423-495c-bf0d-e6532bea7138.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-217-20 | 67457021720 | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-217-20) / 20 mL in 1 VIAL, MULTI-DOSE | 2012-12-20 | 0000-00-00 | No | No | Current |