Home NDC 30698-337-01 Demerol
Product NDC 30698-337
Requested package NDC 30698-337-01
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N005010-001 DEMEROL MEPERIDINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 N005010-002 DEMEROL MEPERIDINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION Approved before 1982 N005010-003 DEMEROL MEPERIDINE HYDROCHLORIDE 100MG/ML INJECTABLE / INJECTION Approved before 1982 N005010-004 DEMEROL MEPERIDINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 N005010-005 DEMEROL MEPERIDINE HYDROCHLORIDE 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL Approved before 1982 N005010-007 DEMEROL MEPERIDINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION Approved before 1982 N005010-009 DEMEROL MEPERIDINE HYDROCHLORIDE 75MG/ML INJECTABLE / INJECTION Approved before 1982
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 8 · 294 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N005010-001 DEMEROL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N005010-002 DEMEROL 50MG/ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N005010-003 DEMEROL 100MG/ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N005010-004 DEMEROL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N005010-005 DEMEROL 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N005010-007 DEMEROL 25MG/ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N005010-009 DEMEROL 75MG/ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N005010-001 DEMEROL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N005010-002 DEMEROL 50MG/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N005010-003 DEMEROL 100MG/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N005010-004 DEMEROL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N005010-005 DEMEROL 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N005010-007 DEMEROL 25MG/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N005010-009 DEMEROL 75MG/ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N005010-001 DEMEROL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N005010-002 DEMEROL 50MG/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N005010-003 DEMEROL 100MG/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N005010-004 DEMEROL 100MG TABLET / ORAL RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N005010-005 DEMEROL 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N005010-007 DEMEROL 25MG/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N005010-009 DEMEROL 75MG/ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N005010-001 DEMEROL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N005010-002 DEMEROL 50MG/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N005010-003 DEMEROL 100MG/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N005010-004 DEMEROL 100MG TABLET / ORAL RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N005010-005 DEMEROL 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N005010-007 DEMEROL 25MG/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N005010-009 DEMEROL 75MG/ML INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N005010-001 DEMEROL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N005010-002 DEMEROL 50MG/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N005010-003 DEMEROL 100MG/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N005010-004 DEMEROL 100MG TABLET / ORAL RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N005010-005 DEMEROL 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N005010-007 DEMEROL 25MG/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N005010-009 DEMEROL 75MG/ML INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N005010-001 DEMEROL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N005010-002 DEMEROL 50MG/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N005010-003 DEMEROL 100MG/ML INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N005010-004 DEMEROL 100MG TABLET / ORAL RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N005010-005 DEMEROL 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SYRUP / ORAL Approved before 1982 b8a1b40f171c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-07-19 19:46 UTC 2019-07 N005010-001 AA 1 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N005010-004 AA 1 ea99ee380514…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2026-01-29 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 2023-12-14 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 2023-01-30 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 2021-02-05 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 2021-01-29 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