METHADONE HYDROCHLORIDE
- Product NDC
- 67877-116
- 11-digit product format
- 678770116
- Labeler code
- 67877
- Product ID
- 67877-116_20153ff4-9230-4650-88de-f63f1a43b7c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHADONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA090635
- Marketing category
- ANDA
- Marketing start
- 2012-01-16
- Marketing end
- 0000-00-00
- Substance
- METHADONE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bc6c52c8-e3e2-9042-21d0-6770dcf1a49b | Product name | 3 | 20250819 |
| a48f0261-b6cc-12b3-49fd-ed131bc5aa96 | Product name | 4 | 20210902 |
| 00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9 | Product name | 6 | 20200708 |
| a6a96832-f31d-b458-45cb-abb8bd940b44 | Product name | 2 | 20200304 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67877-116-01 | 2024-07-30 | C162847 | 48780-1 | 1e7a6dab-1bc6-a2ce-e063-dadaa90aadf7 | These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1947 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67877-116-01 | METHADONE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67877-116-01 | EA - Each | 67877-116 | 7e918bc0-89a5-40ec-bf99-06f597c92e5f | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | ACTIVE INGREDIENT | 229809935B | METHADONE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] | 5 | |
| METHADONE | ACTIVE MOIETY | UC6VBE7V1Z | METHADONE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METHADONE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METHADONE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | METHADONE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 864706 | methadone HCl 10 MG Oral Tablet | PSN | aa8e14c1-fbfd-4e4d-b59e-2d4ae1ca815f | 11 |
| 864706 | methadone hydrochloride 10 MG Oral Tablet | SCD | aa8e14c1-fbfd-4e4d-b59e-2d4ae1ca815f | 11 |
| 864706 | methadone HCl 10 MG Oral Tablet | PSN | 3ce98ab4-346b-4680-b3e1-a8c29b3933af | 10 |
| 864706 | methadone hydrochloride 10 MG Oral Tablet | SCD | 3ce98ab4-346b-4680-b3e1-a8c29b3933af | 10 |
| 864706 | methadone HCl 10 MG Oral Tablet | PSN | 7a8635fe-6183-4cda-9029-50e4e6dd5832 | 4 |
| 864706 | methadone hydrochloride 10 MG Oral Tablet | SCD | 7a8635fe-6183-4cda-9029-50e4e6dd5832 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67877-116-01 | 67877011601 | 100 TABLET in 1 BOTTLE (67877-116-01) | 100 tablet | 2012-01-16 | 0000-00-00 | No | No | Current |