NDC 68084-154-11

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: 68084-154
Requested NDC: 68084-154-11
Package NDCs from labels: 68084-154-11
Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-154-01	EA - Each	68084-154	e1f11fd9-25e0-45a4-8180-de3f4362a717	1	2012-07-24
68084-154-11	EA - Each	68084-154	911f68cd-2986-43b8-ad94-9bc15a057bf8	1	2012-07-24

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 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	84899861-8fed-536d-e053-2991aa0a42b2	2024-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	a4fbc2d8-19b3-4556-b0b9-6e7a14cd4c36	2024-09-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	ea490539-007b-47b1-bef9-22de02ae7c64	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8749824b-6d66-430d-e053-2995a90a2db8	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	da246971-20b8-b46e-8366-9700d3604cf1	2024-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Asclemed USA, Inc.	b4985d9d-1aa0-4b36-bc98-6a5410ad9bad	2024-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	c0c0d4f0-8396-485b-a585-71df01491f6f	2023-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	dcb1694a-8451-403c-b848-edb89ba17020	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	87429921-00d2-42c7-9e99-600e8075b8ce	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Proficient Rx LP	59b906c6-2ccc-416e-b3ee-db09bf553146	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA040596

Reported adverse events (FAERS/openFDA)#

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