Penicillin V Potassium

Product NDC: 62135-099
Requested package NDC: 62135-099-01
11-digit product format: 621350099
Labeler code: 62135
Product ID: 62135-099_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: 500 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…`

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 · 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): 62135-099-01 ndc (product): 62135-099 ndc11 (package): 62135009901
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

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	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 · 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

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
62135-099-01	62135009901	100 TABLET in 1 BOTTLE (62135-099-01)	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