Methadone Hydrochloride
- Product NDC
- 66689-712
- 11-digit product format
- 666890712
- Labeler code
- 66689
- Product ID
- 66689-712_ea0de6af-8e1d-4d04-acc4-10177280badf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methadone Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- VistaPharm, Inc.
- Application
- ANDA090707
- Marketing category
- ANDA
- Marketing start
- 2010-08-01
- Marketing end
- 0000-00-00
- Substance
- METHADONE HYDROCHLORIDE
- Active strength
- 10 mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66689-712-16 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2270-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. Methadone Hydrochloride Oral Solution, for oral use, CII Initial U.S. Approval: 1947 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66689-712-16 | ML - Milliliter | 66689-712 | 59803a0d-601f-4306-814e-3b2521e2dfea | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Methadone Hydrochloride | ACTIVE INGREDIENT | 229809935B | METHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC] | 5 | |
| Methadone | ACTIVE MOIETY | UC6VBE7V1Z | METHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC] | 5 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | METHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC] | 5 | |
| Anhydrous Citric Acid | INACTIVE INGREDIENT | XF417D3PSL | METHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC] | 5 | |
| Benzoic Acid | INACTIVE INGREDIENT | 8SKN0B0MIM | METHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC] | 5 | |
| D&C Red No. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | METHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC] | 5 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | METHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC] | 5 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | METHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC] | 5 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | METHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC] | 5 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | METHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC] | 5 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 66689-712-16 | 66689071216 | 500 mL in 1 BOTTLE (66689-712-16) | 500 ml | 2010-08-01 | 0000-00-00 | No | No | Current |