Methadone Hydrochloride
- Product NDC
- 81298-7500
- 11-digit product format
- 812987500
- Labeler code
- 81298
- Product ID
- 81298-7500_46a3297c-98d2-48ef-a7a9-9776ed80e0bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methadone Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Long Grove Pharmaceuticals, LLC
- Application
- ANDA208306
- Marketing category
- ANDA
- Marketing start
- 2025-06-28
- Substance
- METHADONE HYDROCHLORIDE
- Active strength
- 200 mg/20mL
- 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 | 200 mg/20mL |
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 |
|---|
| 81298-7500-1 | Methadone Hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 2 |
| 81298-7500-1 | Methadone Hydrochloride | 20 mL in 1 VIAL, GLASS | INJECTION | 20 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 81298-7500-1 | 81298750001 | 1 VIAL, GLASS in 1 CARTON (81298-7500-1) / 20 mL in 1 VIAL, GLASS | 2025-06-28 | No | No | Current |