Penicillin V Potassium

Product NDC: 63187-533
11-digit product format: 631870533
Labeler code: 63187
Product ID: 63187-533_d9fdfb61-581b-4082-ac22-60dc2970ffa2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin V Potassium
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA060456
Marketing category: ANDA
Marketing start: 1990-09-30
Substance: PENICILLIN V POTASSIUM
Active strength: 250 mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
PENICILLIN V POTASSIUM	250 mg/5mL

Field, Values table
Field	Values
Unii	146T0TU1JB
Rxcui	834040

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9c9e02f7-1420-b137-8de0-89820016e6ca	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63187-533-00	Penicillin V Potassium	100 mL in 1 BOTTLE	POWDER, FOR SOLUTION	100		5
63187-533-20	Penicillin V Potassium	200 mL in 1 BOTTLE	POWDER, FOR SOLUTION	200		5

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PENICILLIN V POTASSIUM	ACTIVE INGREDIENT	146T0TU1JB	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PROFICIENT RX LP]	1
PENICILLIN V	ACTIVE MOIETY	Z61I075U2W	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PROFICIENT RX LP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PROFICIENT RX LP]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PROFICIENT RX LP]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PROFICIENT RX LP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PROFICIENT RX LP]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-533	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PROFICIENT RX LP]	5	Current NDC, Legacy NDC, 2 package rows	20191121_316aa904-09f1-4a8e-9adf-93cfc14f9a0a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
146T0TU1JB	PENICILLIN V POTASSIUM	132-98-9	PENICILLIN V POTASSIUM

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
834040	penicillin V potassium 250 MG in 5 mL Oral Solution	PSN	316aa904-09f1-4a8e-9adf-93cfc14f9a0a	5
834040	penicillin V potassium 50 MG/ML Oral Solution	SCD	316aa904-09f1-4a8e-9adf-93cfc14f9a0a	5
834040	Penicillin V K+ 50 MG/ML Oral Solution	SY	316aa904-09f1-4a8e-9adf-93cfc14f9a0a	5
834040	Penicillin V Pot 50 MG/ML Oral Solution	SY	316aa904-09f1-4a8e-9adf-93cfc14f9a0a	5
834040	penicillin V potassium 250 MG per 5 ML Oral Solution	SY	316aa904-09f1-4a8e-9adf-93cfc14f9a0a	5
834040	phenoxymethylpenicillin potassium 50 MG/ML Oral Solution	SY	316aa904-09f1-4a8e-9adf-93cfc14f9a0a	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-533-00	63187053300	100 mL in 1 BOTTLE (63187-533-00)	100 ml	2016-08-01	0000-00-00	No	No	Current
63187-533-20	63187053320	200 mL in 1 BOTTLE (63187-533-20)	200 ml	1990-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PENICILLIN V POTASSIUM TABLETS, USP PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USP 4127	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	5