Methadone Hydrochloride
- Product NDC
- 67877-659
- 11-digit product format
- 678770659
- Labeler code
- 67877
- Product ID
- 67877-659_46a9128b-1b83-461f-83b7-75646d009fa7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methadone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA090635
- Marketing category
- ANDA
- Marketing start
- 2025-07-01
- Substance
- METHADONE HYDROCHLORIDE
- Active strength
- 5 mg/1
- 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 229809935B |
| Rxcui | 864706, 864718 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-659-01 | Methadone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-659 | METHADONE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20220819_f0366917-f745-4b01-a662-a98a7d80b4a0.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 |
|---|
| 67877-659-01 | 67877065901 | 100 TABLET in 1 BOTTLE (67877-659-01) | 100 tablet | 2025-07-01 | 0000-00-00 | No | No | Current |