Penicillin V Potassium

Product NDC: 72789-366
Requested package NDC: 72789-366-28
11-digit product format: 727890366
Labeler code: 72789
Product ID: 72789-366_40bb7beb-c449-e526-e063-6294a90abaa1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin V Potassium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 72789-366-28 ndc (product): 72789-366 ndc11 (package): 72789036628
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
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

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
a251a769-280e-4024-ad7a-317746325818	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
72789-366-28	Penicillin V Potassium	28 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	28		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-366-28	EA - Each	72789-366	03125d71-68f1-4a78-ae26-eaf2caf41a73	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-366	PENICILLIN V POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	16	Current NDC, 1 package rows	20240802_a251a769-280e-4024-ad7a-317746325818.zip

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	a251a769-280e-4024-ad7a-317746325818	17
834061	penicillin V potassium 250 MG Oral Tablet	SCD	a251a769-280e-4024-ad7a-317746325818	17
834061	Penicillin V K+ 250 MG Oral Tablet	SY	a251a769-280e-4024-ad7a-317746325818	17
834061	Penicillin V Pot 250 MG Oral Tablet	SY	a251a769-280e-4024-ad7a-317746325818	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72789-366-28	72789036628	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-366-28)	2023-12-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Penicillin V Potassium Tablets	PD-Rx Pharmaceuticals, Inc.	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL	17