Promethazine Hydrochloride

Product NDC: 51655-140
11-digit product format: 516550140
Labeler code: 51655
Product ID: 51655-140_48c3d54f-f13b-5a44-e063-6394a90aa096
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA083426
Marketing category: ANDA
Marketing start: 2023-02-03
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A083426-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A083426-001	AB

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083426-001	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A083426-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083426-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083426-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083426-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083426-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083426-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083426-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083426-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083426-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083426-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083426-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083426-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083426-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083426-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083426-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083426-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083426-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083426-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083426-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083426-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083426-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083426-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083426-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083426-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083426-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083426-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083426-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083426-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083426-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083426-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083426-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083426-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083426-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083426-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083426-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083426-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083426-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083426-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083426-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083426-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Promethazine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	25 mg/1

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
992447	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
f6ca1097-1c75-c682-e053-6294a90a2bd6	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
2e7222fb-e3f1-febd-962f-ddbb495d6b5f	Product name	2	20220126
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
4f881de7-085a-407e-abc2-faa3c0127432	Product name	1	20170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
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
51655-140-52	Promethazine Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30		2
51655-140-53	Promethazine Hydrochloride	10 in 1 BOTTLE, PLASTIC	TABLET	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-140	PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1	Current NDC, 2 package rows	20230315_f6ca1097-1c75-c682-e053-6294a90a2bd6.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	f6ca1097-1c75-c682-e053-6294a90a2bd6	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083426 application number: ANDA083426 ndc (product): 51655-140
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	74834e1b-0d90-0542-e053-2991aa0aa1ef	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083426 application number: ANDA083426
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	08bf9fbf-cc21-41a0-9e81-ec498aa64170	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083426 application number: ANDA083426
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Actavis Pharma, Inc.	a32255f0-0077-489e-bdc6-869aca8cd434	2016-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083426 application number: ANDA083426

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
992447	promethazine HCl 25 MG Oral Tablet	PSN	f6ca1097-1c75-c682-e053-6294a90a2bd6	2
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	f6ca1097-1c75-c682-e053-6294a90a2bd6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-140-52	51655014052	30 TABLET in 1 BOTTLE, PLASTIC (51655-140-52)	30 tablet	2023-02-03	No	No	Current
51655-140-53	51655014053	10 TABLET in 1 BOTTLE, PLASTIC (51655-140-53)	10 tablet	2023-02-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Hydrochloride Tablets USP Revised: December 2016 Rx Only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	2