METHADONE HYDROCHLORIDE
- Product NDC
- 0904-7417
- 11-digit product format
- 009047417
- Labeler code
- 0904
- Product ID
- 0904-7417_51c895c4-90fb-4d88-9032-beea257bec6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHADONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA088109
- Marketing category
- ANDA
- Marketing start
- 2024-01-03
- Substance
- METHADONE HYDROCHLORIDE
- Active strength
- 10 mg/1
- 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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 229809935B |
| Rxcui | 864706 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7417-61 | METHADONE HYDROCHLORIDE | 1 in 1 BLISTER PACK | TABLET | 1 | | 4 |
| 0904-7417-61 | METHADONE HYDROCHLORIDE | 100 in 1 CARTON | TABLET | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7417 | METHADONE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] | 2 | Current NDC, 2 package rows | 20250406_db52fdc0-765a-4fad-a8f9-ef98c6e4b898.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7417-61 | 00904741761 | 100 BLISTER PACK in 1 CARTON (0904-7417-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2024-01-03 | No | No | Current |