Methadone Hydrochloride
- Product NDC
- 0406-4123
- 11-digit product format
- 004064123
- Labeler code
- 0406
- Product ID
- 0406-4123_f3e27571-1978-4639-a625-a7ff53e446d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methadone Hydrochloride
- Dosage form
- CONCENTRATE
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- ANDA207368
- Marketing category
- ANDA
- Marketing start
- 2021-06-18
- 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 | 991147 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0406-4123-03 | Methadone Hydrochloride | 30 mL in 1 BOTTLE, DROPPER | CONCENTRATE | 30 | | 7 |
| 0406-4123-03 | Methadone Hydrochloride | 1 in 1 CARTON | CONCENTRATE | 1 | | 7 |
| 0406-4123-10 | Methadone Hydrochloride | 1000 mL in 1 BOTTLE | CONCENTRATE | 1000 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0406-4123 | METHADONE HYDROCHLORIDE CONCENTRATE [SPECGX LLC] | 4 | Current NDC, Legacy NDC, 3 package rows | 20241116_14f7b1d8-344a-4eaa-a1bf-bc1a00c3ab58.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 |
|---|
| 0406-4123-03 | 00406412303 | 1 BOTTLE, DROPPER in 1 CARTON (0406-4123-03) / 30 mL in 1 BOTTLE, DROPPER | | 2021-06-18 | 0000-00-00 | No | No | Current |
| 0406-4123-10 | 00406412310 | 1000 mL in 1 BOTTLE (0406-4123-10) | 1000 ml | 2021-06-18 | 0000-00-00 | No | No | Current |