Methadone Hydrochloride
- Product NDC
- 51991-002
- 11-digit product format
- 519910002
- Labeler code
- 51991
- Product ID
- 51991-002_eec50ad6-d9ae-42df-ae5e-9cd75199148e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methadone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Breckenridge Pharmaceutical Inc
- Application
- ANDA218252
- Marketing category
- ANDA
- Marketing start
- 2024-12-30
- 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 | 864714 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51991-002-98 | Methadone Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 2 |
| 51991-002-98 | Methadone Hydrochloride | 20 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 20 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51991-002 | METHADONE HYDROCHLORIDE INJECTION, SOLUTION [BRECKENRIDGE PHARMACEUTICAL INC] | 1 | Current NDC, 2 package rows | 20241231_13541167-95f4-4cb9-9d7d-3c1aced5c5f6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51991-002-98 | 51991000298 | 1 VIAL, GLASS in 1 CARTON (51991-002-98) / 20 mL in 1 VIAL, GLASS | 2024-12-30 | No | No | Historical |