Demerol
- Product NDC
- 30698-337
- 11-digit product format
- 306980337
- Labeler code
- 30698
- Product ID
- 30698-337_8b04c129-63c0-422c-88a7-265d1fb6d579
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Meperidine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Validus Pharmaceuticals LLC
- Application
- NDA005010
- Marketing category
- NDA
- Marketing start
- 1942-11-10
- Marketing end
- 0000-00-00
- Substance
- MEPERIDINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- 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 |
|---|
| 30698-337-01 | 2026-01-29 | C162847 | 48780-1 | ba0f9c33-41ee-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use DEMEROL ® TABLETS and ORAL SOLUTION safely and effectively. See full prescribing information for DEMEROL TABLETS and ORAL SOLUTION . DEMEROL (meperidine hydrochloride), tablet s , for oral use, CII DEMEROL (meperidine hydrochloride), oral solution CII Initial U.S. Approval: 1942 |
| 30698-337-01 | 2023-12-14 | C162847 | 48780-1 | ba0f9c33-41ee-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use DEMEROL ® TABLETS and ORAL SOLUTION safely and effectively. See full prescribing information for DEMEROL TABLETS and ORAL SOLUTION . DEMEROL (meperidine hydrochloride), tablet s , for oral use, CII DEMEROL (meperidine hydrochloride), oral solution CII Initial U.S. Approval: 1942 |
| 30698-337-01 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-41ee-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use DEMEROL ® TABLETS and ORAL SOLUTION safely and effectively. See full prescribing information for DEMEROL TABLETS and ORAL SOLUTION . DEMEROL (meperidine hydrochloride), tablet s , for oral use, CII DEMEROL (meperidine hydrochloride), oral solution CII Initial U.S. Approval: 1942 |
| 30698-337-01 | 2021-02-05 | C162847 | 48780-1 | ba0f9c33-41ee-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use DEMEROL ® TABLETS and ORAL SOLUTION safely and effectively. See full prescribing information for DEMEROL TABLETS and ORAL SOLUTION . DEMEROL (meperidine hydrochloride), tablet s , for oral use, CII DEMEROL (meperidine hydrochloride), oral solution CII Initial U.S. Approval: 1942 |
| 30698-337-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-41ee-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use DEMEROL ® TABLETS and ORAL SOLUTION safely and effectively. See full prescribing information for DEMEROL TABLETS and ORAL SOLUTION . DEMEROL (meperidine hydrochloride), tablet s , for oral use, CII DEMEROL (meperidine hydrochloride), oral solution CII Initial U.S. Approval: 1942 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 30698-337-01 | 30698033701 | 100 TABLET in 1 BOTTLE, PLASTIC (30698-337-01) | 100 tablet | 1942-11-10 | 0000-00-00 | No | No | Current |