Application 080364

Type: ANDA
Sponsor: PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/ML	No	No
002	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML	No	No
003	MEPERIDINE HYDROCHLORIDE	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A080364-001	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	Approved before 1982
A080364-002	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982
A080364-003	MEPERIDINE HYDROCHLORIDE	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 3 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-14 00:12 UTC	2019-12	A080364-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080364-001	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A080364-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A080364-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080364-001	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A080364-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A080364-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080364-001	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080364-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080364-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080364-001	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080364-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080364-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080364-001	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080364-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080364-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080364-001	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080364-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080364-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080364-001	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080364-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080364-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080364-001	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080364-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080364-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080364-001	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080364-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080364-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080364-001	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080364-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080364-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080364-001	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080364-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080364-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080364-001	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080364-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080364-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080364-001	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A080364-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A080364-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`

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 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 brand name: Meperidine Hydrochloride 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 brand name: Meperidine Hydrochloride 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 brand name: Meperidine Hydrochloride 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 brand name: MEPERIDINE HYDROCHLORIDE generic name: MEPERIDINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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