Penicillin V Potassium

Product NDC: 16714-235
11-digit product format: 167140235
Labeler code: 16714
Product ID: 16714-235_20659e2d-f79a-447a-87d9-0baeee7567fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin V Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA065435
Marketing category: ANDA
Marketing start: 2008-04-29
Substance: PENICILLIN V POTASSIUM
Active strength: 500 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	500 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
ec25ce45-c0b2-45fa-9211-77f283aad4bd	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16714-235-01	Penicillin V Potassium	100 in 1 BOTTLE	TABLET, FILM COATED	100		7
16714-235-02	Penicillin V Potassium	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-235-01	EA - Each	16714-235	cf8b6683-bb91-4d3b-a34d-509093cc6180	1	2013-02-13
16714-235-02	EA - Each	16714-235	6512bba6-7c01-4321-a51c-52bc54d05781	1	2013-02-13

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 [NORTHSTAR RX LLC]	3
PENICILLIN V	ACTIVE MOIETY	Z61I075U2W	PENICILLIN V POTASSIUM TABLET, FILM COATED [NORTHSTAR RX LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PENICILLIN V POTASSIUM TABLET, FILM COATED [NORTHSTAR RX LLC]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	PENICILLIN V POTASSIUM TABLET, FILM COATED [NORTHSTAR RX LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PENICILLIN V POTASSIUM TABLET, FILM COATED [NORTHSTAR RX LLC]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	PENICILLIN V POTASSIUM TABLET, FILM COATED [NORTHSTAR RX LLC]	3
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	PENICILLIN V POTASSIUM TABLET, FILM COATED [NORTHSTAR RX LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PENICILLIN V POTASSIUM TABLET, FILM COATED [NORTHSTAR RX LLC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PENICILLIN V POTASSIUM TABLET, FILM COATED [NORTHSTAR RX LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PENICILLIN V POTASSIUM TABLET, FILM COATED [NORTHSTAR RX LLC]	3
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
16714-235	PENICILLIN V POTASSIUM TABLET, FILM COATED [NORTHSTAR RX LLC]	7	Current NDC, Legacy NDC, 2 package rows	20221029_ec25ce45-c0b2-45fa-9211-77f283aad4bd.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	ec25ce45-c0b2-45fa-9211-77f283aad4bd	7
834102	penicillin V potassium 500 MG Oral Tablet	PSN	ec25ce45-c0b2-45fa-9211-77f283aad4bd	7
834061	penicillin V potassium 250 MG Oral Tablet	SCD	ec25ce45-c0b2-45fa-9211-77f283aad4bd	7
834102	penicillin V potassium 500 MG Oral Tablet	SCD	ec25ce45-c0b2-45fa-9211-77f283aad4bd	7
834061	Penicillin V K+ 250 MG Oral Tablet	SY	ec25ce45-c0b2-45fa-9211-77f283aad4bd	7
834102	Penicillin V K+ 500 MG Oral Tablet	SY	ec25ce45-c0b2-45fa-9211-77f283aad4bd	7
834061	Penicillin V Pot 250 MG Oral Tablet	SY	ec25ce45-c0b2-45fa-9211-77f283aad4bd	7
834102	Penicillin V Pot 500 MG Oral Tablet	SY	ec25ce45-c0b2-45fa-9211-77f283aad4bd	7
834102	penicillin V potassium 500 MG Oral Tablet	PSN	efdda3a5-77d9-4c66-9da7-2be3f3981b79	5
834102	penicillin V potassium 500 MG Oral Tablet	SCD	efdda3a5-77d9-4c66-9da7-2be3f3981b79	5
834102	Penicillin V K+ 500 MG Oral Tablet	SY	efdda3a5-77d9-4c66-9da7-2be3f3981b79	5
834102	Penicillin V Pot 500 MG Oral Tablet	SY	efdda3a5-77d9-4c66-9da7-2be3f3981b79	5
834102	penicillin V potassium 500 MG Oral Tablet	PSN	b8c3b8f5-bcb3-4f74-8440-54374dfc9974	3
834102	penicillin V potassium 500 MG Oral Tablet	SCD	b8c3b8f5-bcb3-4f74-8440-54374dfc9974	3
834102	Penicillin V K+ 500 MG Oral Tablet	SY	b8c3b8f5-bcb3-4f74-8440-54374dfc9974	3
834102	Penicillin V Pot 500 MG Oral Tablet	SY	b8c3b8f5-bcb3-4f74-8440-54374dfc9974	3
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	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-235-01	16714023501	100 TABLET, FILM COATED in 1 BOTTLE (16714-235-01)	2008-04-29	0000-00-00	No	No	Current
16714-235-02	16714023502	1000 TABLET, FILM COATED in 1 BOTTLE (16714-235-02)	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	Redpharm Drug	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL	2
Penicillin V Potassium Tablets, USP Rx only	A-S Medication Solutions	2023-11-15	Human Prescription Drug Label	3
Penicillin V Potassium Tablets, USP Rx only	A-S Medication Solutions	2023-09-17	Human Prescription Drug Label	5
Penicillin V Potassium Tablets, USP Rx only	NorthStar Rx LLC \| Aurobindo Pharma Limited	2022-10-28	Human Prescription Drug Label	7
Penicillin V Potassium Tablets, USP Rx only	Blenheim Pharmacal, Inc.	2015-03-13	HUMAN PRESCRIPTION DRUG LABEL	1