Promethazine Hydrochloride

Product NDC: 68001-161
11-digit product format: 680010161
Labeler code: 68001
Product ID: 68001-161_3d817fa0-d0c1-9b87-e063-6394a90af502
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA040596
Marketing category: ANDA
Marketing start: 2014-01-13
Substance: PROMETHAZINE HYDROCHLORIDE
Active strength: 12.5 mg/1
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 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	TE codes	Approval date
A040596-001	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18
A040596-002	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18
A040596-003	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040596-001	AB
A040596-002	AB
A040596-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040596-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040596-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040596-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040596-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040596-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040596-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040596-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040596-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040596-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040596-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040596-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040596-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040596-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040596-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040596-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040596-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040596-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040596-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040596-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040596-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040596-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040596-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040596-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040596-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040596-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040596-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040596-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040596-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040596-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040596-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040596-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040596-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040596-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040596-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040596-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040596-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040596-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040596-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040596-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040596-001	AB	1	`8072bd15b7f6…`

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	12.5 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992438	Internal RxNorm lookup
992447	Internal RxNorm lookup
992475	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
44cd6d46-fbb9-4836-9426-d8ce2cb6d66d	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
68001-161-00	Promethazine Hydrochloride	100 in 1 BOTTLE	TABLET	100		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]	2
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PROMETHAZINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]	2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	PROMETHAZINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-161	PROMETHAZINE HYDROCHLORIDE TABLET [BLUEPOINT LABORATORIES]	8	Current NDC, Legacy NDC, 1 package rows	20230906_44cd6d46-fbb9-4836-9426-d8ce2cb6d66d.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Coupler LLC	55f618d1-4466-3200-e063-6394a90a89a8	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	REMEDYREPACK INC.	9e4e57fa-4ce3-4b7b-be5a-381801ed0386	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Sportpharm LLC	4156e780-7ecf-bcae-e063-6394a90a2ae2	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	ASCLEMED USA INC.	4d30e587-6d59-4cf5-ab45-c7639f759df9	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	5590f356-0904-58f6-e063-6294a90a6ad5	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	DIRECT RX	bae9c9c1-107f-0fcb-e053-2a95a90a75b2	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Phenergan	PROMETHAZINE HCL	Direct_Rx	eec705f7-123a-7926-e053-2a95a90af46d	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	REMEDYREPACK INC.	adb04635-584f-4fef-98ca-2574be312a73	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	American Health Packaging	a8fe4bc5-961b-4441-b8e2-ef93e4e137b6	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	American Health Packaging	57b4bf23-c563-4357-9dcf-066cbc1280e4	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	REMEDYREPACK INC.	6728bb41-5d50-4abb-bb73-993dcc16ee66	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	974208c8-4aad-4fb9-991b-cf3085034272	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	BluePoint Laboratories	44cd6d46-fbb9-4836-9426-d8ce2cb6d66d	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596 ndc (product): 68001-161
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Coupler LLC	2d996287-9eed-265a-e063-6294a90a6969	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f4c23037-e415-7604-e053-2995a90a5bb6	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Zydus Lifesciences Limited	4eaa8291-9cde-4205-857b-925ea8d618ba	2024-12-04		Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	6aa6bfcc-024b-4ee2-a586-6c4ca879cea4	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	69eea039-0098-4e2f-a832-152583b16f05	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	b7137912-d119-4899-9c93-09c1c625f290	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	84899861-8fed-536d-e053-2991aa0a42b2	2024-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040596 application number: ANDA040596

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
992438	promethazine HCl 12.5 MG Oral Tablet	PSN	44cd6d46-fbb9-4836-9426-d8ce2cb6d66d	9
992447	promethazine HCl 25 MG Oral Tablet	PSN	44cd6d46-fbb9-4836-9426-d8ce2cb6d66d	9
992475	promethazine HCl 50 MG Oral Tablet	PSN	44cd6d46-fbb9-4836-9426-d8ce2cb6d66d	9
992438	promethazine hydrochloride 12.5 MG Oral Tablet	SCD	44cd6d46-fbb9-4836-9426-d8ce2cb6d66d	9
992447	promethazine hydrochloride 25 MG Oral Tablet	SCD	44cd6d46-fbb9-4836-9426-d8ce2cb6d66d	9
992475	promethazine hydrochloride 50 MG Oral Tablet	SCD	44cd6d46-fbb9-4836-9426-d8ce2cb6d66d	9
992438	promethazine HCl 12.5 MG Oral Tablet	PSN	57b4bf23-c563-4357-9dcf-066cbc1280e4	3
992438	promethazine hydrochloride 12.5 MG Oral Tablet	SCD	57b4bf23-c563-4357-9dcf-066cbc1280e4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-161-00	68001016100	100 TABLET in 1 BOTTLE (68001-161-00)	100 tablet	2014-01-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Hydrochloride Tablets, USP Rx Only 8466001/0224F	American Health Packaging	2025-11-13	HUMAN PRESCRIPTION DRUG LABEL	3
Promethazine Hydrochloride Tablets, USP	BluePoint Laboratories \| Zydus Pharmaceuticals (USA) Inc. \| Cadila Healthcare Limited, Baddi	2025-09-12	HUMAN PRESCRIPTION DRUG LABEL	9