NDC 68084-155-11 - Promethazine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68084-155
Requested NDC: 68084-155-11
Package NDCs from labels: 68084-155-11, 68084-155-01
Manufacturer: American Health Packaging
Effective date: 2025-11-13
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Promethazine Hydrochloride - American Health Packaging	American Health Packaging	2025-11-13	HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride - Cardinal Health	Cardinal Health	2018-12-19	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-155-01	Promethazine Hydrochloride	100 in 1 CARTON	TABLET	100		10
68084-155-11	Promethazine Hydrochloride	1 in 1 BLISTER PACK	TABLET	1		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-155	PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	9	Current NDC, Legacy NDC, 2 package rows	20240415_a8fe4bc5-961b-4441-b8e2-ef93e4e137b6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-155-01	EA - Each	68084-155	daf328c4-4899-42b4-ba38-85588187be71	1	2012-07-24
68084-155-11	EA - Each	68084-155	884ba9b1-fb4d-48cf-bb19-4938ca4e8c6f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	4
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PROMETHAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	PROMETHAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROMETHAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROMETHAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	4

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 7 · 125 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	DIRECT RX	bae9c9c1-107f-0fcb-e053-2a95a90a75b2	2026-09-09	Warnings, Adverse reactions	Exact identifier application number: ANDA040596 rxcui: 992447 unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Redpharm Drug	5a797d11-19b0-fd33-e063-6394a90a4d58	2026-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596 rxcui: 992447 unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	974208c8-4aad-4fb9-991b-cf3085034272	2026-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596 rxcui: 992447 unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Northwind Health Company, LLC	5991de26-891a-153a-e063-6294a90a4633	2026-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596 rxcui: 992447 unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	5590f356-0904-58f6-e063-6294a90a6ad5	2026-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596 rxcui: 992447 unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6bcaa89f-5f14-dc45-e053-2a91aa0aac54	2026-07-30	Warnings, Adverse reactions	Exact identifier rxcui: 992447 unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION	ATLANTIC BIOLOGICALS CORP.	3983d6d3-8bf4-4a88-962f-9bf72fd6e685	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Coupler LLC	55f618d1-4466-3200-e063-6394a90a89a8	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596 rxcui: 992447 unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	REMEDYREPACK INC.	9e4e57fa-4ce3-4b7b-be5a-381801ed0386	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596 rxcui: 992447 unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Sportpharm LLC	4156e780-7ecf-bcae-e063-6394a90a2ae2	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596 rxcui: 992475 rxcui: 992447 rxcui: 992438 unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	ASCLEMED USA INC.	4d30e587-6d59-4cf5-ab45-c7639f759df9	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596 rxcui: 992475 rxcui: 992447 rxcui: 992438 unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	804e2525-d61f-7bed-e053-2991aa0a5daa	2026-06-30	Warnings, Adverse reactions	Exact identifier rxcui: 992447 unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Advagen Pharma Ltd	8b60eff2-5759-4bc3-ac16-5ff80aa153a0	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Camber Pharmaceuticals, Inc.	6a2cd2d6-6e0f-4b2d-be7a-8b99627f4453	2026-06-09	Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488	2026-06-05	Warnings, Adverse reactions	Exact identifier rxcui: 992447 unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47	2026-06-04	Warnings, Adverse reactions	Exact identifier rxcui: 992438 unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8	2026-05-22	Warnings, Adverse reactions	Exact identifier rxcui: 992447 unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f93ca67d-362a-473f-8296-2952da77c074	2026-05-22	Warnings, Adverse reactions	Exact identifier rxcui: 992475 unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d	2026-05-22	Warnings, Adverse reactions	Exact identifier rxcui: 992438 unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Atlantic Biologicals Corp.	5022379d-05ef-63f2-e063-6294a90a2189	2026-04-23	Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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