Promethazine hydrochloride

Manufacturer: Northwind Pharmaceuticals
Effective date: 2014-05-21
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:36:08

Label at a glance#

ProductPromethazine hydrochloride

Active ingredientPROMETHAZINE HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 51655-588-53

MFG: 68382-041-10

Promethazine Hydrochloride 25MG

10 tablets

Rx Only

Lot#: NW58820001

Exp. Date: 05/2015

Each tablet contains: Promethazine hydrochloride, USP....25mg

Dosage: See package insert

Store at 68 to 77 degrees F.

Store in a tight, light-resistant container (See USP).

Keep out of the reach of children.

Mfg by: Cadila Healthcare Ltd. India

Distributed by Zydus Pharmaceuticals USA, Inc Pennington, NJ 08534 Lot# MN5816

Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

Promethazine HCL 25mg 51655-588

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-588-53	2026-01-08	C162847	48780-1	9d75b9d0-a8dc-f424-e053-dadaa90a57ce	0a9b26e5-c31c-41a9-addd-9ce9a7878dc0
51655-588-53	2020-01-31	C162847	48780-1	9d75b9d0-a8dc-f424-e053-dadaa90a57ce	0a9b26e5-c31c-41a9-addd-9ce9a7878dc0

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-588	PROMETHAZINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]	1	Legacy NDC	20140527_0a9b26e5-c31c-41a9-addd-9ce9a7878dc0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-041-01	EA - Each	68382-041	16782f65-a21c-4a53-857c-9715cc63ccc2	1	2012-07-24
68382-041-05	EA - Each	68382-041	e6ab47c3-786c-4ff6-bf66-8867bbe73030	1	2022-11-07
68382-041-10	EA - Each	68382-041	be2eca3b-e059-4a50-98b1-b5411c3020a5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Promethazine hydrochloride
PROMETHAZINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51655-588	51655-588-53
68382-041

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PROMETHAZINE HYDROCHLORIDE	R61ZEH7I1I	ACTIB

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

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 · 129 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
2026-09-14 22:38:34	2026-08	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040596-001	PROMETHAZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AB	2005-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040596-002	PROMETHAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040596-003	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2005-11-18	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A040596-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040596-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040596-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040596-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040596-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040596-003	AB	1	`caaa826d4ba7…`
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…`

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
479c1595-4a17-d496-e063-6394a90a1ecf			0a9b26e5-c31c-41a9-addd-9ce9a7878dc0	2026-01-04		Exact identifier spl set id: 0a9b26e5-c31c-41a9-addd-9ce9a7878dc0
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	c0c0d4f0-8396-485b-a585-71df01491f6f	2023-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 68382-041

Reported adverse events (FAERS/openFDA)#

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