Promethazine Hydrochloride and Dextromethophan Hydrobromide

Product NDC: 50383-803
Requested package NDC: 50383-803-08
11-digit product format: 503830803
Labeler code: 50383
Product ID: 50383-803_852fa99c-9d1e-4175-a481-b31650c8525b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride and Dextromethophan Hydrobromide
Dosage form: SOLUTION
Route: ORAL
Labeler: Akorn
Application: ANDA040027
Marketing category: ANDA
Marketing start: 1996-07-31
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Active strength: 15 mg/5mL; mg/5mL
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50383-803	50383-803-08	D	Discontinued by firm		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
3036445d-7d13-4411-a100-f2ac5ab8a276	Product name	1	20240110
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
2e7222fb-e3f1-febd-962f-ddbb495d6b5f	Product name	2	20220126
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
4f881de7-085a-407e-abc2-faa3c0127432	Product name	1	20170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
d51697af-7f97-0559-95d1-fe94f3f031d5	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50383-803-04	2024-01-30	C162847	48780-1	1030e365-2397-111a-e063-dadaa90a10e2	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION
50383-803-08	2024-01-30	C162847	48780-1	1030e365-2397-111a-e063-dadaa90a10e2	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION
50383-803-16	2024-01-30	C162847	48780-1	1030e365-2397-111a-e063-dadaa90a10e2	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-803-16	ML - Milliliter	50383-803	7af50b88-134e-413d-93fa-5f16f0b52ba5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-803	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHOPHAN HYDROBROMIDE SOLUTION [AKORN]	6	Legacy NDC	20221112_3b78df0c-2c83-41e7-a964-7de0d11c423b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE	58-33-3	PROMETHAZINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-803-08	50383080308	237 mL in 1 BOTTLE (50383-803-08)	237 ml	1996-07-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION	Akorn \| Akorn Operating Company LLC	2022-11-11	HUMAN PRESCRIPTION DRUG LABEL	6