Penicillin V Potassium

Product NDC: 68788-9853
11-digit product format: 687889853
Labeler code: 68788
Product ID: 68788-9853_353e1bf3-0aec-451f-bc7f-6659b95d4962
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin V Potassium
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc
Application: ANDA060456
Marketing category: ANDA
Marketing start: 2012-03-14
Substance: PENICILLIN V POTASSIUM
Active strength: 125 mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A060456-001	PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982
A060456-002	PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982		`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Penicillin V Potassium	PENICILLIN V POTASSIUM	Chartwell RX, LLC	b0744674-ddf7-4022-be2f-2a22bef0d379	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456
Penicillin V Potassium	PENICILLIN V POTASSIUM	Preferred Pharmaceuticals, Inc	8c342c78-47fb-4f6b-9451-68b1f752555c	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456 ndc (product): 68788-9853
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	55a44735-6d6e-3012-e054-00144ff8d46c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	ded0ee2e-56ae-41fe-949c-177614cd8e1f	2023-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456
Penicillin V Potassium	PENICILLIN V POTASSIUM	Teva Pharmaceuticals USA, Inc.	3111ca84-6f8e-45ea-91a1-9cb99c63607e	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456
Penicillin V Potassium	PENICILLIN V POTASSIUM	Proficient Rx LP	316aa904-09f1-4a8e-9adf-93cfc14f9a0a	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456

Additional Listing Data#

Finished product: Yes
Brand name base: Penicillin V Potassium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PENICILLIN V POTASSIUM	125 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
146T0TU1JB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
834040	Internal RxNorm lookup
834046	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8c342c78-47fb-4f6b-9451-68b1f752555c	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-9853-1	Penicillin V Potassium	100 mL in 1 BOTTLE	POWDER, FOR SOLUTION	100		11
68788-9853-2	Penicillin V Potassium	200 mL in 1 BOTTLE	POWDER, FOR SOLUTION	200		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PENICILLIN V POTASSIUM	ACTIVE INGREDIENT	146T0TU1JB	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PREFERRED PHARMACEUTICALS, INC]	2
PENICILLIN V	ACTIVE MOIETY	Z61I075U2W	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PREFERRED PHARMACEUTICALS, INC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PREFERRED PHARMACEUTICALS, INC]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PREFERRED PHARMACEUTICALS, INC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PREFERRED PHARMACEUTICALS, INC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PREFERRED PHARMACEUTICALS, INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-9853	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [PREFERRED PHARMACEUTICALS, INC]	10	Current NDC, Legacy NDC, 2 package rows	20240730_8c342c78-47fb-4f6b-9451-68b1f752555c.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
834046	penicillin V potassium 125 MG in 5 mL Oral Solution	PSN	8c342c78-47fb-4f6b-9451-68b1f752555c	11
834040	penicillin V potassium 250 MG in 5 mL Oral Solution	PSN	8c342c78-47fb-4f6b-9451-68b1f752555c	11
834046	penicillin V potassium 25 MG/ML Oral Solution	SCD	8c342c78-47fb-4f6b-9451-68b1f752555c	11
834040	penicillin V potassium 50 MG/ML Oral Solution	SCD	8c342c78-47fb-4f6b-9451-68b1f752555c	11
834046	Penicillin V K+ 25 MG/ML Oral Solution	SY	8c342c78-47fb-4f6b-9451-68b1f752555c	11
834040	Penicillin V K+ 50 MG/ML Oral Solution	SY	8c342c78-47fb-4f6b-9451-68b1f752555c	11
834046	Penicillin V Pot 25 MG/ML Oral Solution	SY	8c342c78-47fb-4f6b-9451-68b1f752555c	11
834040	Penicillin V Pot 50 MG/ML Oral Solution	SY	8c342c78-47fb-4f6b-9451-68b1f752555c	11
834046	penicillin V potassium 125 MG per 5 ML Oral Solution	SY	8c342c78-47fb-4f6b-9451-68b1f752555c	11
834040	penicillin V potassium 250 MG per 5 ML Oral Solution	SY	8c342c78-47fb-4f6b-9451-68b1f752555c	11
834046	phenoxymethylpenicillin potassium 25 MG/ML Oral Solution	SY	8c342c78-47fb-4f6b-9451-68b1f752555c	11
834040	phenoxymethylpenicillin potassium 50 MG/ML Oral Solution	SY	8c342c78-47fb-4f6b-9451-68b1f752555c	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-9853-1	68788985301	100 mL in 1 BOTTLE (68788-9853-1)	100 ml	2012-03-14	0000-00-00	No	No	Current
68788-9853-2	68788985302	200 mL in 1 BOTTLE (68788-9853-2)	200 ml	2012-03-14	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 Rx only	Preferred Pharmaceuticals, Inc	2025-09-08	HUMAN PRESCRIPTION DRUG LABEL	11