NDC 80425-0265-01 - 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: 80425-0265
Requested NDC: 80425-0265-01
Package NDCs from labels: 80425-0265-1, 80425-0265-01
Manufacturer: Advanced Rx Pharmacy of Tennessee, LLC
Effective date: 2024-12-31
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 - Advanced Rx Pharmacy of Tennessee, LLC	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80425-0265-1	Promethazine Hydrochloride	20 in 1 BOTTLE	TABLET	20		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0265	PROMETHAZINE HYDROCHLORIDE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	2	Current NDC, 1 package rows	20250102_f4c23037-e415-7604-e053-2995a90a5bb6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0265-1	EA - Each	80425-0265	a8a79a83-5300-44ec-b662-8b9ae5ac1a63	1	2023-04-07

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 5 of 7 · 123 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 rxcui: 992447 unii: R61ZEH7I1I
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 rxcui: 992447 unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	07914b6e-c40f-44be-a1db-8724c70f99b6	2024-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
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 rxcui: 992447 unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	Bryant Ranch Prepack	a4b3da5b-1129-43c2-bf22-3a29c3fae116	2024-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
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 rxcui: 992447 unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7e5715cf-056f-4095-e053-2991aa0ad3e5	2024-06-12	Warnings, Adverse reactions	Exact identifier rxcui: 992447 unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	4bf3912c-8339-401e-9711-dad6acf15f11	2024-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
PHENERGAN	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	481866da-a712-48a5-853f-8e84aacaab6d	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
Promethazine Hydrochloride and Codeine Phosphate	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	Bryant Ranch Prepack	df2c24ba-1c88-4ec3-b2a1-801358ec645c	2024-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	b0d5abba-6fae-4f3c-b990-dd9c83c7b5a9	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
Promethazine Hydrochloride	PROMETHAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	365138a6-28d8-4881-a3e9-02c80aaf83e8	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
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 rxcui: 992438 unii: R61ZEH7I1I
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 rxcui: 992475 rxcui: 992447 rxcui: 992438 unii: R61ZEH7I1I
PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a	2024-02-22	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
PROMETHAZINE HCI	PROMETHAZINE HCI	HF Acquisition Co. LLC, DBA HealthFirst	7447e8c6-c198-cd2d-e053-2a91aa0a3895	2024-02-22	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	e451cb8d-f856-479f-bee9-4cccab210b1e	2024-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	XGen Pharmaceuticals DJB, Inc.	b6f6698f-f23c-452a-9b38-bbb96ab88ae4	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	XGen Pharmaceuticals DJB, Inc.	1d02d52b-84bb-4e81-b352-125029eb39f6	2024-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	A-S Medication Solutions	a7b1e8b2-6f20-4096-87c7-cf349ed4f7b9	2023-12-15	Warnings, Adverse reactions	Exact identifier rxcui: 992447 unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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