METHADONE HYDROCHLORIDE
- Product NDC
- 0054-4570
- 11-digit product format
- 000544570
- Labeler code
- 0054
- Product ID
- 0054-4570_b2d1a6bb-c12c-428c-b21f-0d918d247570
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHADONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA006134
- Marketing category
- NDA
- Marketing start
- 2001-10-11
- Marketing end
- 2023-08-31
- 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
- 0000-00-00
- 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0054-4570-25 | EA - Each | 0054-4570 | 15d2d566-f4ae-4380-a2d4-decac9023e95 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | ACTIVE INGREDIENT | 229809935B | METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 1 | |
| METHADONE | ACTIVE MOIETY | UC6VBE7V1Z | METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 864718 | methadone HCl 5 MG Oral Tablet | PSN | ec41ab86-a948-44e4-b21c-c65a22cdf294 | 1 |
| 864718 | methadone hydrochloride 5 MG Oral Tablet | SCD | ec41ab86-a948-44e4-b21c-c65a22cdf294 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0054-4570-25 | 00054457025 | 100 TABLET in 1 BOTTLE, PLASTIC (0054-4570-25) | 100 tablet | 2001-10-11 | 2023-08-31 | No | No | Current |