Methadone Hydrochloride
- Product NDC
- 72865-121
- 11-digit product format
- 728650121
- Labeler code
- 72865
- Product ID
- 72865-121_639b24e8-927d-46ef-82f8-914a10528f21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methadone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- XLCare Pharmaceuticals, Inc
- Application
- ANDA211228
- Marketing category
- ANDA
- Marketing start
- 2019-01-03
- 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, 864718 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72865-121-01 | Methadone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72865-121 | METHADONE HYDROCHLORIDE TABLET [XLCARE PHARMACEUTICALS, INC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240418_1a536622-dda3-41af-ab08-28e7c1bc9300.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 |
|---|
| 72865-121-01 | 72865012101 | 100 TABLET in 1 BOTTLE (72865-121-01) | 100 tablet | 2019-01-03 | 0000-00-00 | No | No | Current |