Methadone Hydrochloride
- Product NDC
- 64850-603
- 11-digit product format
- 648500603
- Labeler code
- 64850
- Product ID
- 64850-603_6745a13f-b53a-4f0d-9c0a-bbef6343a8d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methadone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Elite Laboratories, Inc.
- Application
- ANDA210484
- Marketing category
- ANDA
- Marketing start
- 2018-08-06
- 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
- 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 | 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 |
|---|
| 64850-603-01 | Methadone Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64850-603 | METHADONE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] | 9 | Current NDC, 1 package rows | 20241024_d702d32b-98b1-412d-934c-1cd96af4b95a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64850-603-01 | 64850060301 | 100 TABLET in 1 BOTTLE, PLASTIC (64850-603-01) | 100 tablet | 2018-08-06 | No | No | Historical |