PROMETHAZINE HYDROCHLORIDE

Product NDC: 0116-4023
11-digit product format: 001164023
Labeler code: 0116
Product ID: 0116-4023_302bfe23-7984-140e-e063-6394a90acad1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: promethazine hydrochloride
Dosage form: SYRUP
Route: ORAL
Labeler: Xttrium Laboratories, Inc.
Application: ANDA087953
Marketing category: ANDA
Marketing start: 2025-04-07
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 6.25 mg/5mL
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A087953-001	PROMETHAZINE PLAIN	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087953-001	AA

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RS	1982-11-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087953-001	PROMETHAZINE PLAIN	6.25MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-11-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A087953-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087953-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087953-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087953-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087953-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087953-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087953-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087953-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087953-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087953-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087953-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087953-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087953-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087953-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087953-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087953-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087953-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087953-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087953-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087953-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087953-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087953-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087953-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087953-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087953-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087953-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087953-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087953-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087953-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087953-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087953-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087953-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087953-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087953-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087953-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087953-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087953-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087953-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087953-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087953-001	AA	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: PROMETHAZINE HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	6.25 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R61ZEH7I1I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992432	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
302bfea2-d403-d315-e063-6294a90a37dd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3036445d-7d13-4411-a100-f2ac5ab8a276	Product name	1	20240110
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0116-4023-16	PROMETHAZINE HYDROCHLORIDE	473 mL in 1 BOTTLE, PLASTIC	SYRUP	473		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0116-4023-16	ML - Milliliter	0116-4023	8f8bc199-565a-4913-821b-38f12aa33f8d	1	2025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0116-4023	PROMETHAZINE HYDROCHLORIDE SYRUP [XTTRIUM LABORATORIES, INC.]	1	Current NDC, 1 package rows	20250410_302bfea2-d403-d315-e063-6294a90a37dd.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Atlantic Biologicals Corp.	4f99bbd5-02f7-2fed-e063-6394a90a6355	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087953 application number: ANDA087953
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Xttrium Laboratories, Inc.	302bfea2-d403-d315-e063-6294a90a37dd	2025-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087953 application number: ANDA087953 ndc (product): 0116-4023

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE	58-33-3	PROMETHAZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
992432	promethazine HCl 6.25 MG in 5 mL Oral Solution	PSN	302bfea2-d403-d315-e063-6294a90a37dd	1
992432	promethazine HCl 6.25 MG in 5 mL Oral Solution	PSN	4f99bbd5-02f7-2fed-e063-6394a90a6355	1
992432	promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	302bfea2-d403-d315-e063-6294a90a37dd	1
992432	promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	4f99bbd5-02f7-2fed-e063-6394a90a6355	1
992432	promethazine HCl 6.25 MG per 5 ML Oral Syrup	SY	302bfea2-d403-d315-e063-6294a90a37dd	1
992432	promethazine HCl 6.25 MG per 5 ML Oral Syrup	SY	4f99bbd5-02f7-2fed-e063-6394a90a6355	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0116-4023-16	00116402316	473 mL in 1 BOTTLE, PLASTIC (0116-4023-16)	473 ml	2025-04-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Syrup Plain 6.25 mg/5 mL (Promethazine Hydrochloride Oral Solution, USP)	Atlantic Biologicals Corp.	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	1
Promethazine Syrup Plain 6.25 mg/5 mL (Promethazine Hydrochloride Oral Solution, USP)	Xttrium Laboratories, Inc. \| Halo Pharmaceutical Canada Inc.	2025-04-07	HUMAN PRESCRIPTION DRUG LABEL	1