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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	30698-337		I	Inactivated by FDA		2026-08-07
excluded package	package	30698-337	30698-337-01	I	Inactivated by FDA		2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS
N005010-001	DEMEROL	MEPERIDINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982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N005010-004	DEMEROL	MEPERIDINE HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982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DEMEROL	MEPERIDINE HYDROCHLORIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982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 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005010-007	DEMEROL	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005010-009	DEMEROL	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005010-002	DEMEROL	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005010-003	DEMEROL	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005010-004	DEMEROL	100MG	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`

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#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2957211f-7067-d29a-b09d-73e9648715c8	Product name	1	20140508
c245b765-4133-e5fc-aafb-bfde7c2f8a90	Product name	1	20140508

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
30698-337-01	EA - Each	30698-337	2b547a36-b78f-403b-b990-eeda0b8aa04e	1	2016-09-02

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N8E7F7Q170	MEPERIDINE HYDROCHLORIDE	50-13-5	MEPERIDINE HYDROCHLORIDE

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