METHADONE HYDROCHLORIDE
- Product NDC
- 0054-0709
- 11-digit product format
- 000540709
- Labeler code
- 0054
- Product ID
- 0054-0709_32014633-5c89-4163-9fa7-239777c04d1d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHADONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA088109
- Marketing category
- ANDA
- Marketing start
- 1983-03-08
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0709-20 | METHADONE HYDROCHLORIDE | 1 in 1 CARTON | TABLET | 1 | | 9 |
| 0054-0709-20 | METHADONE HYDROCHLORIDE | 100 in 1 BLISTER PACK | TABLET | 100 | | 9 |
| 0054-0709-25 | METHADONE HYDROCHLORIDE | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0709 | METHADONE HYDROCHLORIDE TABLET [HIKMA PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20250202_50f14803-78c0-4d19-8b5d-9a9c17582ac1.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 |
|---|
| 0054-0709-20 | 00054070920 | 1 BLISTER PACK in 1 CARTON (0054-0709-20) / 100 TABLET in 1 BLISTER PACK | 1 blister pack | 1983-03-08 | 0000-00-00 | No | No | Current |
| 0054-0709-25 | 00054070925 | 100 TABLET in 1 BOTTLE, PLASTIC (0054-0709-25) | 100 tablet | 1983-03-08 | 0000-00-00 | No | No | Current |