Penicillin V Potassium

Product NDC: 70518-3535
11-digit product format: 705183535
Labeler code: 70518
Product ID: 70518-3535_e995a0a9-759a-a84f-e053-2995a90a2c6c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin V Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA090549
Marketing category: ANDA
Marketing start: 2022-09-23
Marketing end: 0000-00-00
Substance: PENICILLIN V POTASSIUM
Active strength: 250 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
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	70518-3535		D	Discontinued by firm		2026-08-03
excluded package	package	70518-3535	70518-3535-0	D	Discontinued by firm		2026-08-03

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 · 20 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	70518-3535-0	`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	70518-3535-0	`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	70518-3535-0	`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	70518-3535-0	`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	70518-3535-0	`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	70518-3535-0	`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	70518-3535-0	`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	70518-3535-0	`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	70518-3535-0	`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	70518-3535-0	`ad56d346431e…`	`cc804d4bbf1e…`

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
A090549-001	PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2013-10-11
A090549-002	PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB		2013-10-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090549-001	AB
A090549-002	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090549-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	2013-10-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090549-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	2013-10-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090549-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090549-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090549-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090549-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090549-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090549-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090549-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090549-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090549-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090549-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090549-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090549-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090549-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090549-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090549-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090549-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090549-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090549-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090549-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090549-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090549-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090549-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090549-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090549-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090549-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090549-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090549-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090549-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090549-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090549-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090549-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090549-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090549-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090549-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090549-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090549-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090549-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090549-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090549-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090549-002	AB	1	`782e0a99824c…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Penicillin V Potassium	PENICILLIN V POTASSIUM	REMEDYREPACK INC.	5f0759cc-c553-49b9-9049-80e713758958	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	Bryant Ranch Prepack	609c3e26-9220-4f3c-b393-a2b41b68de6c	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	ceddc406-4a17-471f-917e-63b4b03779ea	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	a251a769-280e-4024-ad7a-317746325818	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	Bryant Ranch Prepack	bdffe8fe-e6e0-4c08-894c-0653605ff433	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	Preferred Pharmaceuticals Inc.	56192625-0564-4131-94b2-8b9c6a0b53b0	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	8d98ea77-f237-4b93-87fa-41f556436ab5	2025-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	7aef4c8b-aee7-453d-bb6f-fce8e4588e3b	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	fbd3f219-d052-fd00-e053-6294a90a66ac	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	f3f5947d-0dd3-4b50-93a2-bc8325180978	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	93c1177c-35da-464b-be90-bb18fe9bd27d	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	Hikma Pharmaceuticals USA Inc.	dc33f7a4-348b-4b4c-a5f2-c4f908fda4aa	2024-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	e4642fb3-2db9-49d3-8fd4-ceb750f70437	2023-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3535-0	70518353500	40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3535-0)	2022-09-23	0000-00-00	No	No	Current