Penicillin V Potassium

Product NDC: 53002-2130
Requested package NDC: 53002-2130-2
11-digit product format: 530022130
Labeler code: 53002
Product ID: 53002-2130_42f409a1-2330-4d44-a6f2-706f2e6d75fd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin V Potassium
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA060456
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 0000-00-00
Substance: PENICILLIN V POTASSIUM
Active strength: 250 mg/5mL
Pharmacologic classes: Penicillins [CS],Penicillin-class Antibacterial [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-2130	53002-2130-2	I	Inactivated by FDA		2026-09-14

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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`caaa826d4ba7…`
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…`

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…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-2130-1	2025-01-30	Penicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP Rx only
53002-2130-2	2025-01-30	Penicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP Rx only
53002-2130-1	2023-06-07	Penicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP Rx only
53002-2130-2	2023-06-07	Penicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP Rx only
53002-2130-1	2023-01-30	Penicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP Rx only
53002-2130-2	2023-01-30	Penicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP Rx only
53002-2130-1	2020-12-17	Penicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP Rx only
53002-2130-2	2020-12-17	Penicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP Rx only
53002-2130-1	2020-01-31	Penicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP Rx only
53002-2130-2	2020-01-31	Penicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-2130-1	Penicillin V Potassium	100 mL in 1 BOTTLE	POWDER, FOR SOLUTION	100		5
53002-2130-2	Penicillin V Potassium	200 mL in 1 BOTTLE	POWDER, FOR SOLUTION	200		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-2130	PENICILLIN V POTASSIUM POWDER, FOR SOLUTION [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 2 package rows	20230609_465b1fbe-7a9a-4e81-a44e-0ecb3d8472bd.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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	Preferred Pharmaceuticals, Inc	8c342c78-47fb-4f6b-9451-68b1f752555c	2026-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456
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	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

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	465b1fbe-7a9a-4e81-a44e-0ecb3d8472bd	5
834040	penicillin V potassium 50 MG/ML Oral Solution	SCD	465b1fbe-7a9a-4e81-a44e-0ecb3d8472bd	5
834040	Penicillin V K+ 50 MG/ML Oral Solution	SY	465b1fbe-7a9a-4e81-a44e-0ecb3d8472bd	5
834040	Penicillin V Pot 50 MG/ML Oral Solution	SY	465b1fbe-7a9a-4e81-a44e-0ecb3d8472bd	5
834040	penicillin V potassium 250 MG per 5 ML Oral Solution	SY	465b1fbe-7a9a-4e81-a44e-0ecb3d8472bd	5
834040	phenoxymethylpenicillin potassium 50 MG/ML Oral Solution	SY	465b1fbe-7a9a-4e81-a44e-0ecb3d8472bd	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2130-2	53002213002	200 mL in 1 BOTTLE (53002-2130-2)	200 ml	2018-10-01	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	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5