Application 040500

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	SUPPOSITORY;RECTAL	12.5MG	No	No
002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	SUPPOSITORY;RECTAL	25MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040500-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB		2003-06-30
A040500-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB		2003-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040500-001	AB
A040500-002	AB

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 3 · 82 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	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040500-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040500-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	AB	2003-06-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040500-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040500-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040500-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040500-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040500-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040500-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040500-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040500-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040500-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040500-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040500-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040500-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040500-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040500-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040500-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040500-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040500-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040500-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040500-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040500-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040500-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040500-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040500-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040500-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040500-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040500-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040500-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040500-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040500-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040500-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040500-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040500-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040500-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040500-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040500-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040500-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040500-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040500-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040500-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040500-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	46b869e2-9305-43ae-bb15-919a6d09b6ff	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040500 application number: ANDA040500 ndc (product): 50090-2747 ndc (product): 50090-2986
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7d766cf7-a21c-4eaf-bbdc-00f2939ef19a	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040500 application number: ANDA040500 ndc (product): 43063-060
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Asclemed USA, Inc.	1b1cee64-c0b5-4da6-92d0-1769350a5181	2025-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040500 application number: ANDA040500
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	047b9a7c-586b-4635-a63e-2c7ce9ec34e7	2023-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040500 application number: ANDA040500 ndc (product): 45802-758 ndc (product): 45802-759

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-649	Promethazine Hydrochloride	Promethazine Hydrochloride	Rebel Distributors Corp	ANDA	Current
43063-060	Promethazine Hydrochloride	Promethazine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-060	Promethazine Hydrochloride	Promethazine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-060	Promethazine Hydrochloride	Promethazine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-060	Promethazine Hydrochloride	Promethazine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-060	Promethazine Hydrochloride	Promethazine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-060	Promethazine Hydrochloride	Promethazine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45802-758	Promethazine Hydrochloride	Promethazine Hydrochloride	Perrigo New York Inc	ANDA	Current
45802-758	Promethazine Hydrochloride	Promethazine Hydrochloride	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-758	Promethazine Hydrochloride	Promethazine Hydrochloride	Perrigo New York Inc	ANDA	Current
45802-758	Promethazine Hydrochloride	Promethazine Hydrochloride	Perrigo New York Inc	ANDA	Current
45802-759	Promethazine Hydrochloride	Promethazine Hydrochloride	Perrigo New York Inc	ANDA	Current
45802-759	Promethazine Hydrochloride	Promethazine Hydrochloride	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-759	Promethazine Hydrochloride	Promethazine Hydrochloride	Perrigo New York Inc	ANDA	Current
45802-759	Promethazine Hydrochloride	Promethazine Hydrochloride	Perrigo New York Inc	ANDA	Current
50090-2747	Promethazine Hydrochloride	Promethazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2747	Promethazine Hydrochloride	Promethazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2747	Promethazine Hydrochloride	Promethazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2986	Promethazine Hydrochloride	Promethazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2986	Promethazine Hydrochloride	Promethazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2986	Promethazine Hydrochloride	Promethazine Hydrochloride	A-S Medication Solutions	ANDA	Current
63629-8445	Promethazine Hydrochloride	Promethazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8445	Promethazine Hydrochloride	Promethazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8445	Promethazine Hydrochloride	Promethazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8446	Promethazine Hydrochloride	Promethazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8446	Promethazine Hydrochloride	Promethazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8446	Promethazine Hydrochloride	Promethazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current