Application 005010

Type: NDA
Sponsor: US PHARM HOLDINGS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEMEROL	MEPERIDINE HYDROCHLORIDE	TABLET;ORAL	50MG	Yes	No
002	DEMEROL	MEPERIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML	No	No
003	DEMEROL	MEPERIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/ML	No	No
004	DEMEROL	MEPERIDINE HYDROCHLORIDE	TABLET;ORAL	100MG	Yes	No
005	DEMEROL	MEPERIDINE HYDROCHLORIDE	SYRUP;ORAL	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
007	DEMEROL	MEPERIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/ML	No	No
009	DEMEROL	MEPERIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	75MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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N005010-001	DEMEROL	MEPERIDINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982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N005010-004	DEMEROL	MEPERIDINE HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982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DEMEROL	MEPERIDINE HYDROCHLORIDE	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	Approved before 1982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 4 of 8 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-04-08 23:34 UTC	2022-04	N005010-002	DEMEROL	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N005010-003	DEMEROL	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N005010-004	DEMEROL	100MG	TABLET / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N005010-005	DEMEROL	50MG/5ML	SYRUP / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N005010-007	DEMEROL	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N005010-009	DEMEROL	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N005010-001	DEMEROL	50MG	TABLET / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N005010-002	DEMEROL	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N005010-003	DEMEROL	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N005010-004	DEMEROL	100MG	TABLET / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N005010-005	DEMEROL	50MG/5ML	SYRUP / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N005010-007	DEMEROL	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N005010-009	DEMEROL	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N005010-001	DEMEROL	50MG	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N005010-002	DEMEROL	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N005010-003	DEMEROL	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N005010-004	DEMEROL	100MG	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N005010-005	DEMEROL	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N005010-007	DEMEROL	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N005010-009	DEMEROL	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N005010-001	DEMEROL	50MG	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N005010-002	DEMEROL	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N005010-003	DEMEROL	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N005010-004	DEMEROL	100MG	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N005010-007	DEMEROL	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N005010-009	DEMEROL	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N005010-001	DEMEROL	50MG	TABLET / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N005010-002	DEMEROL	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N005010-003	DEMEROL	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N005010-004	DEMEROL	100MG	TABLET / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N005010-005	DEMEROL	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N005010-007	DEMEROL	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N005010-009	DEMEROL	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N005010-001	DEMEROL	50MG	TABLET / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N005010-002	DEMEROL	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N005010-003	DEMEROL	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N005010-004	DEMEROL	100MG	TABLET / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N005010-005	DEMEROL	50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N005010-007	DEMEROL	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`

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…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEMEROL	MEPERIDINE HYDROCHLORIDE	Hospira, Inc.	b31d1308-28c3-43f4-e0a6-2f3ed76b8975	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DEMEROL generic name: MEPERIDINE HYDROCHLORIDE
Meperidine Hydrochloride	MEPERIDINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	15bc51a8-1e24-4d33-9a2f-05a41c29acf0	2026-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEPERIDINE HYDROCHLORIDE
Meperidine Hydrochloride	MEPERIDINE HYDROCHLORIDE	Genus Lifesciences Inc.	792fefda-6cc4-4709-b902-fd9787fc310a	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEPERIDINE HYDROCHLORIDE
Meperidine Hydrochloride	MEPERIDINE HYDROCHLORIDE	EPIC PHARMA, LLC	fae5cc34-5917-4445-9516-25f97ffca8db	2025-11-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEPERIDINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	e0e998da-f056-4fce-be8e-ed60cf3b461b	2024-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEPERIDINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
30698-335	Demerol	Meperidine Hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-335	Demerol	Meperidine Hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-335	Demerol	Meperidine Hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-335	Demerol	Meperidine Hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-337	Demerol	Meperidine Hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-337	Demerol	Meperidine Hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-337	Demerol	Meperidine Hydrochloride	Validus Pharmaceuticals LLC	NDA	Current
30698-337	Demerol	Meperidine Hydrochloride	Validus Pharmaceuticals LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84695	SUPPL	2026-01-06
84694	SUPPL	2026-01-06
84548	SUPPL	2025-12-29
80067	SUPPL	2024-11-04
76875	SUPPL	2023-12-18
76222	ORIG	2023-11-03
66524	SUPPL	2021-03-05
66523	SUPPL	2021-03-05
66510	SUPPL	2021-03-05
60295	SUPPL	2019-10-08
60293	SUPPL	2019-10-08
60292	SUPPL	2019-10-08
55841	SUPPL	2018-10-05
55839	SUPPL	2018-10-05
55838	SUPPL	2018-10-05
55645	SUPPL	2018-09-28
55644	SUPPL	2018-09-28
49572	SUPPL	2017-08-29
49449	SUPPL	2017-08-17
46420	SUPPL	2016-12-21
46194	SUPPL	2016-12-19
59	SUPPL	2011-11-02
10676	SUPPL	2011-10-31
13	SUPPL	2011-04-13
10675	SUPPL	2011-04-11
10674	SUPPL	2009-03-17
12	SUPPL	2009-03-10
58	SUPPL	2003-06-08
11	SUPPL	2003-03-10