Application 040027

Type: ANDA
Sponsor: HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	SYRUP;ORAL	15MG/5ML;6.25MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL			1996-07-31

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 · 44 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
2026-10-15 13:18:30	2026-09	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1996-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1996-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1996-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1996-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040027-001	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	15MG/5ML;6.25MG/5ML	SYRUP / ORAL		1996-07-31	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040027-001	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A040027-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040027-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040027-001	AA	1	`ea99ee380514…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Advagen Pharma Ltd	8b60eff2-5759-4bc3-ac16-5ff80aa153a0	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Camber Pharmaceuticals, Inc.	6a2cd2d6-6e0f-4b2d-be7a-8b99627f4453	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Atlantic Biologicals Corp.	5022379d-05ef-63f2-e063-6294a90a2189	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Bryant Ranch Prepack	709519cb-d124-4469-b329-b67e1bba214b	2026-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Cranbury Pharmaceuticals, LLC	a8b57027-a4b8-4149-93e8-aa3e7a6d6dc3	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Cosette Pharmaceuticals, Inc.	e7b336d9-b1df-4a08-9b67-754346d365f4	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	87f9e9fb-5433-478b-9f23-e16883a9d2a9	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	ANI Pharmaceuticals, Inc.	a52e210f-b99d-493e-b679-ec565c6ff72d	2025-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Asclemed USA, Inc.	702eb7c0-db4c-4729-b69e-99f64c63c7bd	2025-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Xttrium Laboratories, Inc	30c9d769-bc74-04d2-e063-6294a90a665a	2025-04-07	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Amneal Pharmaceuticals LLC	6081c216-0bed-40f0-8732-f999647003d5	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	e451cb8d-f856-479f-bee9-4cccab210b1e	2024-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	ee227c52-2cd8-4a06-a2de-a257f1f4732a	2023-07-11	Warnings, Adverse reactions	Name fallback brand name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-803	Promethazine Hydrochloride and Dextromethophan Hydrobromide	Promethazine Hydrochloride and Dextromethophan Hydrobromide	Akorn	ANDA	Current
50383-803	Promethazine Hydrochloride and Dextromethophan Hydrobromide	Promethazine Hydrochloride and Dextromethophan Hydrobromide	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-803	Promethazine Hydrochloride and Dextromethophan Hydrobromide	Promethazine Hydrochloride and Dextromethophan Hydrobromide	Hi-Tech Pharmacal Co., Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42565	ORIG	2003-07-30