Application 040558

Type: ANDA
Sponsor: ABLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	12.5MG	No	No
002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A040558-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01
A040558-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-01
A040558-003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2004-07-01

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040558-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040558-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040558-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2004-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040558-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040558-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040558-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2004-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040558-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040558-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040558-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2004-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040558-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040558-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040558-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2004-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040558-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040558-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040558-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2004-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040558-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040558-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040558-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2004-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040558-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040558-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040558-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2004-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040558-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040558-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040558-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2004-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040558-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040558-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040558-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2004-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040558-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040558-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040558-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2004-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040558-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040558-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040558-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2004-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040558-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040558-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040558-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2004-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040558-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040558-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2004-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040558-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2004-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040558-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	2004-07-01	`8072bd15b7f6…`

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 5 · 94 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6bcaa89f-5f14-dc45-e053-2a91aa0aac54	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Coupler LLC	55f618d1-4466-3200-e063-6394a90a89a8	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	REMEDYREPACK INC.	9e4e57fa-4ce3-4b7b-be5a-381801ed0386	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Sportpharm LLC	4156e780-7ecf-bcae-e063-6394a90a2ae2	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	ASCLEMED USA INC.	4d30e587-6d59-4cf5-ab45-c7639f759df9	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	5590f356-0904-58f6-e063-6294a90a6ad5	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	804e2525-d61f-7bed-e053-2991aa0a5daa	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f93ca67d-362a-473f-8296-2952da77c074	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Atlantic Biologicals Corp.	4f99bbd5-02f7-2fed-e063-6394a90a6355	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	bf951b5b-6e38-44a9-895e-0d60c6b9d343	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	81fd29a9-c090-49ba-8b48-bd3656ca0c92	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	KVK-Tech, Inc.	7a137adf-39b7-4b14-80da-c3cac9ad562a	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	DIRECT RX	bae9c9c1-107f-0fcb-e053-2a95a90a75b2	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE generic name: PROMETHAZINE HYDROCHLORIDE
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

Application 040558

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#