Penicillin V Potassium

Product NDC: 67296-2308
Requested package NDC: 67296-2308-4
11-digit product format: 672962308
Labeler code: 67296
Product ID: 67296-2308_58e6fd67-476b-f81c-e063-6294a90a69e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin V Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Redpharm Drug
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: 2027-12-31
Current FDA listing: Yes

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
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 · 86 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
2026-09-14 22:38:34	2026-08	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065435-001	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2008-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065435-002	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	RS	2008-04-29	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065435-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065435-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065435-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065435-002	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Penicillin V Potassium
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
834061	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
58e6fd2f-e595-f788-e063-6394a90a0ea2	Available on FDA.report

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 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	861ccfaa-8b7a-0def-e053-2991aa0a1a39	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435
Penicillin V Potassium	PENICILLIN V POTASSIUM	Redpharm Drug	58e6fd2f-e595-f788-e063-6394a90a0ea2	2026-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065435 application number: ANDA065435 ndc (package): 67296-2308-4 ndc (product): 67296-2308 ndc11 (package): 67296230804
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

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	Sample	Exclude flag	Status
67296-2308-4	67296230804	40 TABLET, FILM COATED in 1 BOTTLE (67296-2308-4)	2008-04-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Penicillin V Potassium Tablets, USP Rx only	Redpharm Drug	2026-08-13	HUMAN PRESCRIPTION DRUG LABEL	1