Penicillin V Potassium

Product NDC: 10544-075
11-digit product format: 105440075
Labeler code: 10544
Product ID: 10544-075_11319112-6ee1-32e7-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin V Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA065435
Marketing category: ANDA
Marketing start: 2012-05-24
Marketing end: 0000-00-00
Substance: PENICILLIN V POTASSIUM
Active strength: 500 mg/1
Pharmacologic classes: Penicillins [CS],Penicillin-class Antibacterial [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	10544-075		I	Inactivated by FDA		2026-08-03
excluded package	package	10544-075	10544-075-30	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-075-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-075-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-075-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-075-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-075-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-075-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-075-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-075-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-075-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-075-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-075-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-075-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-075-30	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-075-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-075-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-075-30	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-075-30	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-075-30	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-075-30	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-075-30	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	10544-075-30	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	10544-075-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A065435-001	PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29
A065435-002	PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065435-001	AB
A065435-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB		2008-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB		2008-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB		2008-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB		2008-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB		2008-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB		2008-04-29	`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	A065435-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065435-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065435-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065435-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065435-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065435-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065435-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065435-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065435-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065435-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065435-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065435-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065435-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065435-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065435-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065435-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065435-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065435-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065435-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065435-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065435-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065435-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065435-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065435-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065435-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065435-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065435-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065435-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065435-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065435-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065435-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065435-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065435-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065435-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065435-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065435-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065435-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065435-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065435-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065435-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
9c9e02f7-1420-b137-8de0-89820016e6ca	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-075-30	2020-01-31	C162847	48780-1	9d75b9d0-f88c-f424-e053-dadaa90a57ce	Penicillin V Potassium Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-075-30	Penicillin V Potassium	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PENICILLIN V POTASSIUM	ACTIVE INGREDIENT	146T0TU1JB	PENICILLIN V POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
PENICILLIN V	ACTIVE MOIETY	Z61I075U2W	PENICILLIN V POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PENICILLIN V POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	PENICILLIN V POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PENICILLIN V POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	PENICILLIN V POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	PENICILLIN V POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PENICILLIN V POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PENICILLIN V POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PENICILLIN V POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-075	PENICILLIN V POTASSIUM TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 1 package rows	20150316_11319112-6ee0-32e7-e054-00144ff8d46c.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 2 · 37 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.	fba1ffe5-809a-495b-bf3e-f2099ac459f6	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	REMEDYREPACK INC.	8f9fa2c8-4d25-48a8-9257-43c33d08e83a	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	REMEDYREPACK INC.	b5972712-f735-46ed-a94a-b84668bb6a82	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	Redpharm Drug	546c367a-c786-8326-e063-6294a90ae76c	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	Proficient Rx LP	b8f797fb-979c-4eab-a3a6-ad4edcb9ff07	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	QPharma Inc	8c11af69-146f-47ed-b12a-7b201fec7e50	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	9bc7006d-a482-47c4-a138-5380ce927812	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	4ad879d4-eb32-49f0-af73-c47fc7581936	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	450ad3aa-7c9e-497b-b00e-b1af0322f8d0	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	0151c742-7525-4707-af03-bd48d50cd586	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	281f9c32-e28a-46ae-9e4e-c2143aaa6c6b	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	aa90bf0b-c08d-43e5-b247-1a5c5e3c94e4	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	73cd20d5-2521-4b93-a221-fa3fe490eba6	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	Bryant Ranch Prepack	dde7b33e-84fc-41c9-97f8-10308841200d	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals, Inc.	4af2a165-0b7d-2539-e054-00144ff8d46c	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	1c49ef5c-75bb-f9d4-e063-6394a90a951a	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	946dbeaa-17ec-4049-e053-2995a90a1462	2025-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	fd784ff4-86ec-9ea4-e053-6394a90a8969	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	65e59e7a-0ec6-2a76-e053-2991aa0a0021	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	887a719a-4e5f-4e04-9935-7ad7ce75cabe	2024-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435

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
834102	penicillin V potassium 500 MG Oral Tablet	PSN	11319112-6ee0-32e7-e054-00144ff8d46c	1
834102	penicillin V potassium 500 MG Oral Tablet	SCD	11319112-6ee0-32e7-e054-00144ff8d46c	1
834102	Penicillin V K+ 500 MG Oral Tablet	SY	11319112-6ee0-32e7-e054-00144ff8d46c	1
834102	Penicillin V Pot 500 MG Oral Tablet	SY	11319112-6ee0-32e7-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-075-30	10544007530	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Penicillin V Potassium Tablets, USP Rx only	Blenheim Pharmacal, Inc.	2015-03-13	HUMAN PRESCRIPTION DRUG LABEL	1