Phenobarbital

Product NDC: 54932-207
11-digit product format: 549320207
Labeler code: 54932
Product ID: 54932-207_55e5fd1b-cf3b-4d80-8c36-a7bbd06284ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenobarbital
Dosage form: LIQUID
Route: ORAL
Labeler: BioRamo, LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2018-03-03
Marketing end: 0000-00-00
Substance: PHENOBARBITAL
Active strength: 20 mg/5mL
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54932-207		I	Inactivated by FDA		2026-11-13
excluded package	package	54932-207	54932-207-81	I	Inactivated by FDA		2026-11-13

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54932-207-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54932-207-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54932-207-81	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54932-207-81	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54932-207-81	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54932-207-81	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54932-207-81	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54932-207-81	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54932-207-81	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54932-207-81	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54932-207-81	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54932-207-81	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54932-207-81	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54932-207-81	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54932-207-81	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54932-207-81	2024-01-30	C162847	48780-1	d6a99b39-51bf-a426-e053-dadaa90af4c2	PHENOBARBITAL ORAL SOLUTION, USP CIV
54932-207-81	2022-03-03	C162847	48780-1	d6a99b39-51bf-a426-e053-dadaa90af4c2	PHENOBARBITAL ORAL SOLUTION, USP CIV
54932-207-81	2022-01-28	C162847	48780-1	d6a99b39-51bf-a426-e053-dadaa90af4c2	PHENOBARBITAL ORAL SOLUTION, USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54932-207-81	Phenobarbital	473 mL in 1 BOTTLE	LIQUID	473		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54932-207-81	ML - Milliliter	54932-207	35f462aa-304f-41ab-977a-083dcc006446	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54932-207	PHENOBARBITAL LIQUID [BIORAMO, LLC]	3	Legacy NDC, 1 package rows	20220304_86086e0e-fef1-411a-aafe-14bd3fc40edd.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
702519	PHENobarbital 20 MG in 5 mL Oral Solution	PSN	86086e0e-fef1-411a-aafe-14bd3fc40edd	3
702519	phenobarbital 4 MG/ML Oral Solution	SCD	86086e0e-fef1-411a-aafe-14bd3fc40edd	3
702519	phenobarbital 20 MG per 5 ML Oral Solution	SY	86086e0e-fef1-411a-aafe-14bd3fc40edd	3
702519	phenobarbital 30 MG per 7.5 ML Oral Solution	SY	86086e0e-fef1-411a-aafe-14bd3fc40edd	3
702519	phenobarbital 60 MG per 15 ML Oral Solution	SY	86086e0e-fef1-411a-aafe-14bd3fc40edd	3
702519	PHENobarbital 20 MG in 5 mL Oral Solution	PSN	73b5e1f4-40a6-4009-9b2c-6401c7538586	1
702519	phenobarbital 4 MG/ML Oral Solution	SCD	73b5e1f4-40a6-4009-9b2c-6401c7538586	1
702519	phenobarbital 20 MG per 5 ML Oral Solution	SY	73b5e1f4-40a6-4009-9b2c-6401c7538586	1
702519	phenobarbital 30 MG per 7.5 ML Oral Solution	SY	73b5e1f4-40a6-4009-9b2c-6401c7538586	1
702519	phenobarbital 60 MG per 15 ML Oral Solution	SY	73b5e1f4-40a6-4009-9b2c-6401c7538586	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54932-207-81	54932020781	473 mL in 1 BOTTLE (54932-207-81)	473 ml	2018-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENOBARBITAL ORAL SOLUTION, USP CIV	BioRamo, LLC	2022-03-03	HUMAN PRESCRIPTION DRUG LABEL	3
PHENOBARBITAL ORAL SOLUTION, USP CIV	ATLANTIC BIOLOGICALS CORP	2018-03-16	HUMAN PRESCRIPTION DRUG LABEL	1