Application 080445

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/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
004	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
A080445-001	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982
A080445-002	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982
A080445-003	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982
A080445-004	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A080445-001	AP
A080445-002	AP
A080445-003	AP
A080445-004	AP

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 5 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A080445-001	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A080445-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A080445-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A080445-004	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080445-001	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080445-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080445-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080445-004	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080445-001	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080445-002	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080445-003	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080445-004	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A080445-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080445-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080445-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080445-004	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080445-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080445-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080445-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080445-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080445-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080445-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080445-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080445-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080445-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080445-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080445-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080445-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080445-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080445-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080445-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080445-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080445-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080445-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080445-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080445-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080445-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080445-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080445-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080445-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080445-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080445-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080445-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080445-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080445-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080445-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080445-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080445-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080445-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080445-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080445-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080445-004	AP	1	`5bbf6a4d5a75…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	e0e998da-f056-4fce-be8e-ed60cf3b461b	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080445 application number: ANDA080445 ndc (product): 0641-6054 ndc (product): 0641-6052 ndc (product): 0641-6053

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-6052	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6052	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6052	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6053	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6053	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6053	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6054	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6054	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6054	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ANDA	Current