Application 040893

Type: ANDA
Sponsor: ANDA REPOSITORY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
002	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	TABLET;ORAL	75MG	No	No
003	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
004	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No

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

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	Approval date
A040893-001	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-06-24
A040893-002	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	75MG	TABLET / ORAL		2009-06-24
A040893-003	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL		2009-06-24
A040893-004	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	150MG	TABLET / ORAL		2009-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040893-001	AA

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040893-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040893-002	MEPERIDINE HYDROCHLORIDE	75MG	TABLET / ORAL		2009-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040893-003	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL		2009-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040893-004	MEPERIDINE HYDROCHLORIDE	150MG	TABLET / ORAL		2009-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040893-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040893-002	MEPERIDINE HYDROCHLORIDE	75MG	TABLET / ORAL		2009-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040893-003	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL		2009-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040893-004	MEPERIDINE HYDROCHLORIDE	150MG	TABLET / ORAL		2009-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040893-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040893-002	MEPERIDINE HYDROCHLORIDE	75MG	TABLET / ORAL		2009-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040893-003	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL		2009-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040893-004	MEPERIDINE HYDROCHLORIDE	150MG	TABLET / ORAL		2009-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040893-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040893-002	MEPERIDINE HYDROCHLORIDE	75MG	TABLET / ORAL		2009-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040893-003	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL		2009-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040893-004	MEPERIDINE HYDROCHLORIDE	150MG	TABLET / ORAL		2009-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040893-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040893-002	MEPERIDINE HYDROCHLORIDE	75MG	TABLET / ORAL		2009-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040893-003	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL		2009-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040893-004	MEPERIDINE HYDROCHLORIDE	150MG	TABLET / ORAL		2009-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040893-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040893-002	MEPERIDINE HYDROCHLORIDE	75MG	TABLET / ORAL		2009-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040893-003	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL		2009-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040893-004	MEPERIDINE HYDROCHLORIDE	150MG	TABLET / ORAL		2009-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040893-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040893-002	MEPERIDINE HYDROCHLORIDE	75MG	TABLET / ORAL		2009-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040893-003	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL		2009-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040893-004	MEPERIDINE HYDROCHLORIDE	150MG	TABLET / ORAL		2009-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040893-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040893-002	MEPERIDINE HYDROCHLORIDE	75MG	TABLET / ORAL		2009-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040893-003	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL		2009-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040893-004	MEPERIDINE HYDROCHLORIDE	150MG	TABLET / ORAL		2009-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040893-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040893-002	MEPERIDINE HYDROCHLORIDE	75MG	TABLET / ORAL		2009-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040893-003	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL		2009-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040893-004	MEPERIDINE HYDROCHLORIDE	150MG	TABLET / ORAL		2009-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040893-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040893-002	MEPERIDINE HYDROCHLORIDE	75MG	TABLET / ORAL		2009-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040893-003	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL		2009-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040893-004	MEPERIDINE HYDROCHLORIDE	150MG	TABLET / ORAL		2009-06-24	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040893-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040893-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040893-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040893-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040893-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040893-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040893-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040893-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040893-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040893-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040893-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040893-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040893-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040893-001	AA	1	`8072bd15b7f6…`
2019-07-19 19:46 UTC	2019-07	A040893-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040893-003	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040893-001	AA	1	`6a51e52b5d6a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040893-001	AA	1	`a50c72e98297…`

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	Genus Lifesciences Inc.	792fefda-6cc4-4709-b902-fd9787fc310a	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040893 application number: ANDA040893

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
46672-829	meperidine hydrochloride	meperidine hydrochloride	Mikart, LLC	ANDA	Current
46672-829	meperidine hydrochloride	meperidine hydrochloride	Mikart, LLC	ANDA	Current
46672-830	meperidine hydrochloride	meperidine hydrochloride	Mikart, LLC	ANDA	Current
46672-830	meperidine hydrochloride	meperidine hydrochloride	Mikart, LLC	ANDA	Current
46672-831	meperidine hydrochloride	meperidine hydrochloride	Mikart, LLC	ANDA	Current
46672-831	meperidine hydrochloride	meperidine hydrochloride	Mikart, LLC	ANDA	Current
46672-832	meperidine hydrochloride	meperidine hydrochloride	Mikart, LLC	ANDA	Current
46672-832	meperidine hydrochloride	meperidine hydrochloride	Mikart, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76119	ORIG	2023-11-03