METHADONE HYDROCHLORIDE
- Product NDC
- 61919-670
- 11-digit product format
- 619190670
- Labeler code
- 61919
- Product ID
- 61919-670_9c98d740-5c6f-292b-e053-2a95a90ac1c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHADONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- NDA006134
- Marketing category
- NDA
- Marketing start
- 2019-07-23
- 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
- 2021-12-31
- 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 |
|---|---|---|---|---|---|
| 61919-670-60 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-86a0-a426-e053-dadaa90af4c2 | METHADONE HYDROCHLORIDE |
| 61919-670-90 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2743-a910-e053-dadaa90a0b85 | METHADONE HYDROCHLORIDE |
| 61919-670-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f15d-f424-e053-dadaa90a57ce | METHADONE HYDROCHLORIDE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-670-30 | METHADONE HYDROCHLORIDE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 2 | |
| 61919-670-60 | METHADONE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET | 60 | 2 | |
| 61919-670-90 | METHADONE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-670-30 | EA - Each | 61919-670 | e54550f9-a65d-4de2-9002-d8c4e08d4126 | 1 | 2016-09-02 |
| 61919-670-60 | EA - Each | 61919-670 | 22c8c932-7946-499b-af44-31fa1d764c57 | 1 | 2019-08-06 |
| 61919-670-90 | EA - Each | 61919-670 | 58eb1fe4-90f8-4335-bf5d-30b0a882aae9 | 1 | 2019-08-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | ACTIVE INGREDIENT | 229809935B | METHADONE HYDROCHLORIDE TABLET [DIRECT RX] | 1 | |
| METHADONE | ACTIVE MOIETY | UC6VBE7V1Z | METHADONE HYDROCHLORIDE TABLET [DIRECT RX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METHADONE HYDROCHLORIDE TABLET [DIRECT RX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METHADONE HYDROCHLORIDE TABLET [DIRECT RX] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | METHADONE HYDROCHLORIDE TABLET [DIRECT RX] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61919-670 | METHADONE HYDROCHLORIDE TABLET [DIRECT RX] | 2 | Legacy NDC, 1 package rows | 20160606_af2fa7bc-5d43-47d8-835e-b9adc565600a.zip |
| 61919-670 | METHADONE HYDROCHLORIDE TABLET [DIRECT_RX] | 2 | Legacy NDC, 1 package rows | 20200121_8e5ce0ae-b6fc-cfea-e053-2995a90a3d44.zip |
| 61919-670 | METHADONE HYDROCHLORIDE TABLET [DIRECT_RX] | 1 | Legacy NDC, 1 package rows | 20190724_8e5bc5d9-f8c3-3a34-e053-2995a90a8fb7.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 864706 | methadone HCl 10 MG Oral Tablet | PSN | 8e5ce0ae-b6fc-cfea-e053-2995a90a3d44 | 2 |
| 864706 | methadone HCl 10 MG Oral Tablet | PSN | af2fa7bc-5d43-47d8-835e-b9adc565600a | 2 |
| 864706 | methadone hydrochloride 10 MG Oral Tablet | SCD | 8e5ce0ae-b6fc-cfea-e053-2995a90a3d44 | 2 |
| 864706 | methadone hydrochloride 10 MG Oral Tablet | SCD | af2fa7bc-5d43-47d8-835e-b9adc565600a | 2 |
| 864706 | methadone HCl 10 MG Oral Tablet | PSN | 8e5bc5d9-f8c3-3a34-e053-2995a90a8fb7 | 1 |
| 864706 | methadone hydrochloride 10 MG Oral Tablet | SCD | 8e5bc5d9-f8c3-3a34-e053-2995a90a8fb7 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-670-30 | 61919067030 | 30 in 1 BOTTLE, PLASTIC | Historical | |||||
| 61919-670-60 | 61919067060 | 60 TABLET in 1 BOTTLE (61919-670-60) | 60 tablet | 2019-07-23 | 0000-00-00 | No | No | Current |
| 61919-670-90 | 61919067090 | 90 in 1 BOTTLE | Historical |