Penicillin V Potassium

Product NDC: 65862-175
11-digit product format: 658620175
Labeler code: 65862
Product ID: 65862-175_7b3fb934-771d-4f76-9abe-8002861dd633
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin V Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA065435
Marketing category: ANDA
Marketing start: 2008-04-29
Substance: PENICILLIN V POTASSIUM
Active strength: 250 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
unfinished product	product	65862-175		UNFINISHED	Active or certified unfinished drug listing		2026-08-03
unfinished package	package	65862-175	65862-175-35	UNFINISHED	Active or certified unfinished drug listing		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 · 42 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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-175-35	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-175-35	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-175-35	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-175-35	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-175-35	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-175-35	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-175-35	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-175-35	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-175-35	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-175-35	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-175-35	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-175-35	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-175-35	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-175-35	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-175-35	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-175-35	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-175-35	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-175-35	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-175-35	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-175-35	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	65862-175-35	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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…`

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/1

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
834061	Internal RxNorm lookup
834102	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
cfc0df21-fb6f-447d-96f6-f851732f9e2f	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
65862-175-01	Penicillin V Potassium	100 in 1 BOTTLE	TABLET, FILM COATED	100		12
65862-175-99	Penicillin V Potassium	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-175-01	EA - Each	65862-175	285667d5-3024-4af2-b861-dc9a49a9da43	1	2012-07-24
65862-175-99	EA - Each	65862-175	7ce6ebf9-80e1-48e5-ba6d-3cd355e30e35	1	2012-07-24

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 [AUROBINDO PHARMA LIMITED]	8
PENICILLIN V	ACTIVE MOIETY	Z61I075U2W	PENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	PENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	PENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	PENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-175	PENICILLIN V POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	12	Current NDC, Legacy NDC, 2 package rows	20220221_cfc0df21-fb6f-447d-96f6-f851732f9e2f.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
834061	penicillin V potassium 250 MG Oral Tablet	PSN	9bc7006d-a482-47c4-a138-5380ce927812	25
834061	penicillin V potassium 250 MG Oral Tablet	SCD	9bc7006d-a482-47c4-a138-5380ce927812	25
834061	Penicillin V K+ 250 MG Oral Tablet	SY	9bc7006d-a482-47c4-a138-5380ce927812	25
834061	Penicillin V Pot 250 MG Oral Tablet	SY	9bc7006d-a482-47c4-a138-5380ce927812	25
834061	penicillin V potassium 250 MG Oral Tablet	PSN	cfc0df21-fb6f-447d-96f6-f851732f9e2f	12
834102	penicillin V potassium 500 MG Oral Tablet	PSN	cfc0df21-fb6f-447d-96f6-f851732f9e2f	12
834061	penicillin V potassium 250 MG Oral Tablet	SCD	cfc0df21-fb6f-447d-96f6-f851732f9e2f	12
834102	penicillin V potassium 500 MG Oral Tablet	SCD	cfc0df21-fb6f-447d-96f6-f851732f9e2f	12
834061	Penicillin V K+ 250 MG Oral Tablet	SY	cfc0df21-fb6f-447d-96f6-f851732f9e2f	12
834102	Penicillin V K+ 500 MG Oral Tablet	SY	cfc0df21-fb6f-447d-96f6-f851732f9e2f	12
834061	Penicillin V Pot 250 MG Oral Tablet	SY	cfc0df21-fb6f-447d-96f6-f851732f9e2f	12
834102	Penicillin V Pot 500 MG Oral Tablet	SY	cfc0df21-fb6f-447d-96f6-f851732f9e2f	12
834061	penicillin V potassium 250 MG Oral Tablet	PSN	4ed73ebb-bcef-4d03-90a7-5c93fad6138b	11
834061	penicillin V potassium 250 MG Oral Tablet	SCD	4ed73ebb-bcef-4d03-90a7-5c93fad6138b	11
834061	Penicillin V K+ 250 MG Oral Tablet	SY	4ed73ebb-bcef-4d03-90a7-5c93fad6138b	11
834061	Penicillin V Pot 250 MG Oral Tablet	SY	4ed73ebb-bcef-4d03-90a7-5c93fad6138b	11
834061	penicillin V potassium 250 MG Oral Tablet	PSN	e4110912-be79-49cf-a855-72702fddea92	10
834061	penicillin V potassium 250 MG Oral Tablet	SCD	e4110912-be79-49cf-a855-72702fddea92	10
834061	Penicillin V K+ 250 MG Oral Tablet	SY	e4110912-be79-49cf-a855-72702fddea92	10
834061	Penicillin V Pot 250 MG Oral Tablet	SY	e4110912-be79-49cf-a855-72702fddea92	10
834061	penicillin V potassium 250 MG Oral Tablet	PSN	65e59e7a-0ec6-2a76-e053-2991aa0a0021	5
834061	penicillin V potassium 250 MG Oral Tablet	SCD	65e59e7a-0ec6-2a76-e053-2991aa0a0021	5
834061	Penicillin V K+ 250 MG Oral Tablet	SY	65e59e7a-0ec6-2a76-e053-2991aa0a0021	5
834061	Penicillin V Pot 250 MG Oral Tablet	SY	65e59e7a-0ec6-2a76-e053-2991aa0a0021	5
834061	penicillin V potassium 250 MG Oral Tablet	PSN	4af2a165-0b7d-2539-e054-00144ff8d46c	4
834061	penicillin V potassium 250 MG Oral Tablet	SCD	4af2a165-0b7d-2539-e054-00144ff8d46c	4
834061	Penicillin V K+ 250 MG Oral Tablet	SY	4af2a165-0b7d-2539-e054-00144ff8d46c	4
834061	Penicillin V Pot 250 MG Oral Tablet	SY	4af2a165-0b7d-2539-e054-00144ff8d46c	4
834061	penicillin V potassium 250 MG Oral Tablet	PSN	502297e7-8e92-3315-e054-00144ff8d46c	3
834061	penicillin V potassium 250 MG Oral Tablet	SCD	502297e7-8e92-3315-e054-00144ff8d46c	3
834061	Penicillin V K+ 250 MG Oral Tablet	SY	502297e7-8e92-3315-e054-00144ff8d46c	3
834061	Penicillin V Pot 250 MG Oral Tablet	SY	502297e7-8e92-3315-e054-00144ff8d46c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-175-01	65862017501	100 TABLET, FILM COATED in 1 BOTTLE (65862-175-01)	2008-04-29	0000-00-00	No	No	Current
65862-175-35	65862017535	3500 TABLET, FILM COATED in 1 BAG (65862-175-35)	29-APR-08				Current
65862-175-99	65862017599	1000 TABLET, FILM COATED in 1 BOTTLE (65862-175-99)	2008-04-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Penicillin V Potassium Tablets, USP Rx only	REMEDYREPACK INC.	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	3
Penicillin V Potassium Tablets, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-16	HUMAN PRESCRIPTION DRUG LABEL	25
Penicillin V Potassium Tablets, USP Rx only	NuCare Pharmaceuticals, Inc.	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	4
Penicillin V Potassium Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2024-12-06	HUMAN PRESCRIPTION DRUG LABEL	5
Penicillin V Potassium Tablets, USP Rx only	Aurobindo Pharma Limited	2022-02-19	Human Prescription Drug Label	12
Penicillin V Potassium - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
Penicillin V Potassium Tablets, USP Rx only	A-S Medication Solutions	2021-02-26	Human Prescription Drug Label	11
Penicillin V Potassium Tablets, USP Rx only	A-S Medication Solutions	2021-02-26	Human Prescription Drug Label	10
Penicillin V Potassium Tablets, USP Rx only	NuCare Pharmaceuticals, Inc.	2017-06-08	HUMAN PRESCRIPTION DRUG LABEL	1