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

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A060456-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060456-002	AA	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	A060456-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A060456-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A060456-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A060456-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A060456-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A060456-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A060456-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A060456-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A060456-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A060456-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A060456-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A060456-002	AA	1	`ea99ee380514…`

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
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 ndc (product): 63187-533

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	250 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
834040	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
316aa904-09f1-4a8e-9adf-93cfc14f9a0a	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
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

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 [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

DailyMed Dashboard NDC Coverage#

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

DailyMed RxNorm Mappings#

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

Packages#

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