METHADONE HYDROCHLORIDE
- Product NDC
- 35356-834
- 11-digit product format
- 353560834
- Labeler code
- 35356
- Product ID
- 35356-834_86d7bc7d-8be0-4fa6-a3ae-47be9a0f2286
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHADONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- NDA006134
- Marketing category
- NDA
- Marketing start
- 2008-01-01
- 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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 35356-834-01 | 2023-01-10 | C162847 | 48780-1 | d6a99b39-fdc5-a426-e053-dadaa90af4c2 | db37a292-5685-4f10-92fc-57631e1a25f9 |
| 35356-834-30 | 2023-01-10 | C162847 | 48780-1 | d6a99b39-fdc5-a426-e053-dadaa90af4c2 | db37a292-5685-4f10-92fc-57631e1a25f9 |
| 35356-834-60 | 2023-01-10 | C162847 | 48780-1 | d6a99b39-fdc5-a426-e053-dadaa90af4c2 | db37a292-5685-4f10-92fc-57631e1a25f9 |
| 35356-834-90 | 2023-01-10 | C162847 | 48780-1 | d6a99b39-fdc5-a426-e053-dadaa90af4c2 | db37a292-5685-4f10-92fc-57631e1a25f9 |
| 35356-834-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-fdc5-a426-e053-dadaa90af4c2 | db37a292-5685-4f10-92fc-57631e1a25f9 |
| 35356-834-30 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-fdc5-a426-e053-dadaa90af4c2 | db37a292-5685-4f10-92fc-57631e1a25f9 |
| 35356-834-60 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-fdc5-a426-e053-dadaa90af4c2 | db37a292-5685-4f10-92fc-57631e1a25f9 |
| 35356-834-90 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-fdc5-a426-e053-dadaa90af4c2 | db37a292-5685-4f10-92fc-57631e1a25f9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 35356-834-01 | EA - Each | 35356-834 | bd2e1a94-5d0c-4731-9f26-d26c6d879b72 | 1 | 2013-04-01 |
| 35356-834-30 | EA - Each | 35356-834 | c7f86c32-4508-422d-bb4c-1e4f7da0c0a9 | 1 | 2013-04-01 |
| 35356-834-60 | EA - Each | 35356-834 | a9e04eca-9cec-4f98-9555-6f100fee36f5 | 1 | 2013-04-01 |
| 35356-834-90 | EA - Each | 35356-834 | 874950ed-05b2-4389-b908-2e6720494508 | 1 | 2013-04-01 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 35356-834-01 | 35356083401 | 120 TABLET in 1 BOTTLE, PLASTIC (35356-834-01) | 120 tablet | 2008-01-01 | 0000-00-00 | No | No | Current |
| 35356-834-30 | 35356083430 | 30 TABLET in 1 BOTTLE, PLASTIC (35356-834-30) | 30 tablet | 2008-01-01 | 0000-00-00 | No | No | Current |
| 35356-834-90 | 35356083490 | 90 TABLET in 1 BOTTLE, PLASTIC (35356-834-90) | 90 tablet | 2008-01-01 | 0000-00-00 | No | No | Current |