Methadone Hydrochloride
- Product NDC
- 17856-3554
- 11-digit product format
- 178563554
- Labeler code
- 17856
- Product ID
- 17856-3554_97bdff8b-376c-4eb5-8ee9-8e6bbd656d3c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methadone Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA087393
- Marketing category
- ANDA
- Marketing start
- 2019-03-13
- Marketing end
- 0000-00-00
- Substance
- METHADONE HYDROCHLORIDE
- Active strength
- 5 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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 17856-3554-1 | 2024-05-20 | C162847 | 48780-1 | f386c649-f328-0266-e053-dadaa90a7c1a | 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 |
| 17856-3554-2 | 2024-05-20 | C162847 | 48780-1 | f386c649-f328-0266-e053-dadaa90a7c1a | 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 |
| 17856-3554-3 | 2024-05-20 | C162847 | 48780-1 | f386c649-f328-0266-e053-dadaa90a7c1a | 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 |
| 17856-3554-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-f328-0266-e053-dadaa90a7c1a | 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 |
| 17856-3554-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-f328-0266-e053-dadaa90a7c1a | 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 |
| 17856-3554-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-f328-0266-e053-dadaa90a7c1a | 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17856-3554-1 | Methadone Hydrochloride | 5 mL in 1 SYRINGE | SOLUTION | 5 | | 5 |
| 17856-3554-1 | Methadone Hydrochloride | 48 in 1 BOX, UNIT-DOSE | SOLUTION | 48 | | 5 |
| 17856-3554-2 | Methadone Hydrochloride | 48 in 1 BOX, UNIT-DOSE | SOLUTION | 48 | | 5 |
| 17856-3554-2 | Methadone Hydrochloride | 5 mL in 1 SYRINGE | SOLUTION | 5 | | 5 |
| 17856-3554-3 | Methadone Hydrochloride | 72 in 1 BOX, UNIT-DOSE | SOLUTION | 72 | | 5 |
| 17856-3554-3 | Methadone Hydrochloride | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17856-3554 | METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.] | 5 | Legacy NDC, 6 package rows | 20240522_eff99966-a35c-4952-a9aa-1344da90b9eb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 17856-3554-1 | 17856355401 | 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-3554-1) > 5 mL in 1 SYRINGE | 48 syringe | 2021-01-26 | 0000-00-00 | No | No | Current |
| 17856-3554-2 | 17856355402 | 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-3554-2) > 5 mL in 1 SYRINGE | 48 syringe | 2021-01-26 | 0000-00-00 | No | No | Current |
| 17856-3554-3 | 17856355403 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-3554-3) > 10 mL in 1 CUP, UNIT-DOSE | | 2021-04-29 | 0000-00-00 | No | No | Current |