NDC 0641-6099-01 - 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: 0641-6099
Requested NDC: 0641-6099-01
Package NDCs from labels: 0641-6099-01, 0641-6099-25
Manufacturer: West-ward Pharmaceutical Corp. | West-ward Pharmaceutical Corp
Effective date: 2011-09-15
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
PROMETHAZINE - West-ward Pharmaceutical Corp. \| West-ward Pharmaceutical Corp	West-ward Pharmaceutical Corp. \| West-ward Pharmaceutical Corp	2011-09-15	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0641-6099-25	2024-06-05	C162847	48780-1	960f7f55-d58f-8e05-e053-dbdaa90a074a	Promethazine Hydrochloride Injection, USP Rx only
0641-6099-25	2019-10-29	C162847	48780-1	960f7f55-d58f-8e05-e053-dbdaa90a074a	Promethazine Hydrochloride Injection, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6099-01	ML - Milliliter	0641-6099	44485d47-ac32-4783-97cd-c5cb391cca8d	1	2012-07-24
0641-6099-25	ML - Milliliter	0641-6099	c055dafe-ee66-446f-963b-9f3d22150d8a	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 INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
PHENOL	INACTIVE INGREDIENT	339NCG44TV	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	5

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 29 of 29 · 561 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12		Exact identifier unii: M4I0D6VV5M

Reported adverse events (FAERS/openFDA)#

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