Penicillin V Potassium

Product NDC: 62135-098
Requested package NDC: 62135-098-01
11-digit product format: 621350098
Labeler code: 62135
Product ID: 62135-098_574b2e4e-febe-2db9-e063-6394a90a3474
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin V Potassium
Dosage form: TABLET
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA060711
Marketing category: ANDA
Marketing start: 1990-09-30
Substance: PENICILLIN V POTASSIUM
Active strength: 250 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC]; Penicillins [CS]
Listing certified through: 2027-12-31
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
A060711-002	PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982
A060711-003	PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A060711-002	AB
A060711-003	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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`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	A060711-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060711-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060711-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060711-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A060711-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060711-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060711-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060711-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060711-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060711-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060711-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060711-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060711-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060711-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060711-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060711-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060711-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060711-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A060711-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A060711-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060711-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060711-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060711-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060711-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060711-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060711-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A060711-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060711-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060711-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060711-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A060711-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060711-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A060711-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060711-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A060711-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060711-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A060711-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A060711-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A060711-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A060711-003	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
834040	Internal RxNorm lookup
834046	Internal RxNorm lookup
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
b0744674-ddf7-4022-be2f-2a22bef0d379	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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Penicillin V Potassium	PENICILLIN V POTASSIUM	Chartwell RX, LLC	b0744674-ddf7-4022-be2f-2a22bef0d379	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060711 application number: ANDA060711 ndc (package): 62135-098-01 ndc (product): 62135-098 ndc11 (package): 62135009801
Penicillin V Potassium	PENICILLIN V POTASSIUM	REMEDYREPACK INC.	dd8a48b2-9ff1-49de-a53e-db4964c2384c	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060711 application number: ANDA060711
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	ada3be87-2cdb-75f7-e053-2995a90aa95b	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060711 application number: ANDA060711
Penicillin V Potassium	PENICILLIN V POTASSIUM	Teva Pharmaceuticals USA, Inc.	3111ca84-6f8e-45ea-91a1-9cb99c63607e	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060711 application number: ANDA060711

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	Units	Marketing start	Sample	Status
62135-098-01	62135009801	100 TABLET in 1 BOTTLE (62135-098-01)	100 tablet	2026-07-23	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Penicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP	Chartwell RX, LLC	2026-07-23	HUMAN PRESCRIPTION DRUG LABEL	2