Application 040504

Type: ANDA
Sponsor: ABLE

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 43.

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
A040504-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL			2003-04-11
A040504-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL			2003-04-11

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040504-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	SUPPOSITORY / RECTAL	2003-04-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040504-002	PROMETHAZINE HYDROCHLORIDE	25MG	SUPPOSITORY / RECTAL	2003-04-11	`74a2ff9319b5…`

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 2 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Henry Schein, Inc.	7fa840ad-10e7-4faf-9325-451648604161	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	REMEDYREPACK INC.	adb04635-584f-4fef-98ca-2574be312a73	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Chartwell RX, LLC	2ca17cd4-460e-4d54-8c53-a58a2b80e5cb	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	7ce351d8-47be-4937-aad2-153208c93b53	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	f6ca1097-1c75-c682-e053-6294a90a2bd6	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	d9cb1a44-d646-d9e9-e053-2995a90a24ff	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	075f052e-7f38-7f75-e063-6394a90a512b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	ba4ec2d8-1da4-473b-9ef8-57051cb2c0f7	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	0b5734b8-6a52-44ff-ac29-9a91a4335394	2025-12-20	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	ProPharma Distribution	38673af1-112e-9ddd-e063-6294a90af465	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride	PROMETHAZINE HYDROCHLORIDE	Cranbury Pharmaceuticals, LLC	d32ea9db-11d4-400d-b7ef-dd0ec01b796d	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: promethazine hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	ProPharma Distribution	45b09a50-dab2-e83d-e063-6394a90aa813	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride	PROMETHAZINE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP	69934bbb-922c-4752-b253-f2f07340de8d	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: promethazine hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	46b869e2-9305-43ae-bb15-919a6d09b6ff	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	e5d2156d-1f66-4fdf-a3ae-5e1325218c8b	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	American Health Packaging	a8fe4bc5-961b-4441-b8e2-ef93e4e137b6	2025-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	American Health Packaging	57b4bf23-c563-4357-9dcf-066cbc1280e4	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Henry Schein, Inc.	d7675718-0a57-41ff-a771-79afc12150aa	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Henry Schein, Inc.	c525cb2c-9a01-4a9b-ad2c-08630719953d	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	e16238dc-9292-49ac-b80f-8afeccb88bc5	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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