Application 088744

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	SYRUP;ORAL	50MG/5ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088744-001	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL		RS	1985-01-30

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088744-001	MEPERIDINE HYDROCHLORIDE	50MG/5ML	SYRUP / ORAL	RS	1985-01-30	`e64feba35796…`

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.	15bc51a8-1e24-4d33-9a2f-05a41c29acf0	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088744 application number: ANDA088744 ndc (product): 0054-3545

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-3545	Meperidine Hydrochloride	Meperidine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3545	Meperidine Hydrochloride	Meperidine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3545	Meperidine Hydrochloride	Meperidine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3545	Meperidine Hydrochloride	Meperidine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3545	Meperidine Hydrochloride	Meperidine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3545	Meperidine Hydrochloride	Meperidine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3545	Meperidine Hydrochloride	Meperidine Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76205	ORIG	2023-11-03