METHADONE HYDROCHLORIDE
- Product NDC
- 0406-6221
- 11-digit product format
- 004066221
- Labeler code
- 0406
- Product ID
- 0406-6221_4e01f70c-6006-4f0d-9fc9-a50788fe3fd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHADONE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- ANDA207537
- Marketing category
- ANDA
- Marketing start
- 2021-06-18
- Substance
- METHADONE HYDROCHLORIDE
- Active strength
- 10 mg/5mL
- 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/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 229809935B |
| Rxcui | 864761, 864769 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0406-6221-05 | METHADONE HYDROCHLORIDE | 500 mL in 1 BOTTLE | SOLUTION | 500 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0406-6221 | METHADONE HYDROCHLORIDE SOLUTION [SPECGX LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240725_5baef1bf-8bf0-429c-a4ce-1c93171f3f15.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 |
|---|
| 0406-6221-05 | 00406622105 | 500 mL in 1 BOTTLE (0406-6221-05) | 500 ml | 2021-06-18 | 0000-00-00 | No | No | Current |