Penicillin V Potassium

Product NDC: 71335-2702
11-digit product format: 713352702
Labeler code: 71335
Product ID: 71335-2702_055a5a60-fa76-45cc-85b3-487840acd552
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin V Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA090549
Marketing category: ANDA
Marketing start: 2013-10-11
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090549-001	PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB		2013-10-11
A090549-002	PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB		2013-10-11

Therapeutic equivalence codes#

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

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

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

Observed Orange Book normalized TE history#

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

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

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 · 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
bdffe8fe-e6e0-4c08-894c-0653605ff433	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
71335-2702-1	Penicillin V Potassium	40 in 1 BOTTLE	TABLET, FILM COATED	40		1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Penicillin V Potassium	PENICILLIN V POTASSIUM	REMEDYREPACK INC.	5f0759cc-c553-49b9-9049-80e713758958	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	Bryant Ranch Prepack	609c3e26-9220-4f3c-b393-a2b41b68de6c	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	ceddc406-4a17-471f-917e-63b4b03779ea	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	a251a769-280e-4024-ad7a-317746325818	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	Bryant Ranch Prepack	bdffe8fe-e6e0-4c08-894c-0653605ff433	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549 ndc (product): 71335-2702
Penicillin V Potassium	PENICILLIN V POTASSIUM	Preferred Pharmaceuticals Inc.	56192625-0564-4131-94b2-8b9c6a0b53b0	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	8d98ea77-f237-4b93-87fa-41f556436ab5	2025-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	7aef4c8b-aee7-453d-bb6f-fce8e4588e3b	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	fbd3f219-d052-fd00-e053-6294a90a66ac	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	f3f5947d-0dd3-4b50-93a2-bc8325180978	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	93c1177c-35da-464b-be90-bb18fe9bd27d	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	Hikma Pharmaceuticals USA Inc.	dc33f7a4-348b-4b4c-a5f2-c4f908fda4aa	2024-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	e4642fb3-2db9-49d3-8fd4-ceb750f70437	2023-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090549 application number: ANDA090549

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
834061	penicillin V potassium 250 MG Oral Tablet	PSN	bdffe8fe-e6e0-4c08-894c-0653605ff433	1
834061	penicillin V potassium 250 MG Oral Tablet	SCD	bdffe8fe-e6e0-4c08-894c-0653605ff433	1
834061	Penicillin V K+ 250 MG Oral Tablet	SY	bdffe8fe-e6e0-4c08-894c-0653605ff433	1
834061	Penicillin V Pot 250 MG Oral Tablet	SY	bdffe8fe-e6e0-4c08-894c-0653605ff433	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2702-1	71335270201	40 TABLET, FILM COATED in 1 BOTTLE (71335-2702-1)	2025-09-26	No	No	Current