PHENOBARBITAL

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70752-157	70752-157-12	I	Inactivated by FDA		2026-10-12

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

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e3e67a66-d325-4d80-8f9d-059e736d7b00	Product name	1	20230912

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70752-157-12	2023-02-02	C162847	48780-1	f386c649-f080-0266-e053-dadaa90a7c1a	PHENOBARBITAL ORAL SOLUTION, USP CIV Rx only
70752-157-12	2023-01-30	C162847	48780-1	f386c649-f080-0266-e053-dadaa90a7c1a	PHENOBARBITAL ORAL SOLUTION, USP CIV Rx only

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70752-157-12	PHENOBARBITAL	473 mL in 1 BOTTLE	SOLUTION	473		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70752-157	PHENOBARBITAL SOLUTION [QUAGEN PHARMACEUTICALS LLC]	2	Legacy NDC, 1 package rows	20230203_f96c7937-4968-4e14-b2f0-0dd5f79ae841.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YQE403BP4D	PHENOBARBITAL	50-06-6	PHENOBARBITAL

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
702519	PHENobarbital 20 MG in 5 mL Oral Solution	PSN	f96c7937-4968-4e14-b2f0-0dd5f79ae841	2
702519	phenobarbital 4 MG/ML Oral Solution	SCD	f96c7937-4968-4e14-b2f0-0dd5f79ae841	2
702519	phenobarbital 20 MG per 5 ML Oral Solution	SY	f96c7937-4968-4e14-b2f0-0dd5f79ae841	2
702519	phenobarbital 30 MG per 7.5 ML Oral Solution	SY	f96c7937-4968-4e14-b2f0-0dd5f79ae841	2
702519	phenobarbital 60 MG per 15 ML Oral Solution	SY	f96c7937-4968-4e14-b2f0-0dd5f79ae841	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70752-157-12	70752015712	473 mL in 1 BOTTLE (70752-157-12)	473 ml	2020-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENOBARBITAL ORAL SOLUTION, USP CIV Rx only	QUAGEN PHARMACEUTICALS LLC	2023-02-02	HUMAN PRESCRIPTION DRUG LABEL	2