Application 060003

Type: ANDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	V-CILLIN K	PENICILLIN V POTASSIUM	TABLET;ORAL	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	V-CILLIN K	PENICILLIN V POTASSIUM	TABLET;ORAL	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
003	V-CILLIN K	PENICILLIN V POTASSIUM	TABLET;ORAL	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A060003-001	V-CILLIN K	PENICILLIN V POTASSIUM	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982
A060003-002	V-CILLIN K	PENICILLIN V POTASSIUM	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982
A060003-003	V-CILLIN K	PENICILLIN V POTASSIUM	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060003-002	V-CILLIN K	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060003-003	V-CILLIN K	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060003-001	V-CILLIN K	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060003-002	V-CILLIN K	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060003-003	V-CILLIN K	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060003-001	V-CILLIN K	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060003-002	V-CILLIN K	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060003-003	V-CILLIN K	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A060003-001	V-CILLIN K	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060003-002	V-CILLIN K	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060003-003	V-CILLIN K	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060003-001	V-CILLIN K	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060003-002	V-CILLIN K	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060003-003	V-CILLIN K	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A060003-001	V-CILLIN K	EQ 125MG BASE	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060003-002	V-CILLIN K	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060003-003	V-CILLIN K	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A060003-001	V-CILLIN K	EQ 125MG BASE	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060003-002	V-CILLIN K	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060003-003	V-CILLIN K	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A060003-001	V-CILLIN K	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060003-002	V-CILLIN K	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060003-003	V-CILLIN K	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A060003-001	V-CILLIN K	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A060003-002	V-CILLIN K	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A060003-003	V-CILLIN K	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A060003-001	V-CILLIN K	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A060003-002	V-CILLIN K	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A060003-003	V-CILLIN K	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A060003-001	V-CILLIN K	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A060003-002	V-CILLIN K	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A060003-003	V-CILLIN K	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A060003-001	V-CILLIN K	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A060003-002	V-CILLIN K	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A060003-003	V-CILLIN K	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A060003-001	V-CILLIN K	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A060003-002	V-CILLIN K	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A060003-003	V-CILLIN K	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A060003-001	V-CILLIN K	EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A060003-002	V-CILLIN K	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`

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 3 · 59 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.	dd8a48b2-9ff1-49de-a53e-db4964c2384c	2026-09-03	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	861ccfaa-8b7a-0def-e053-2991aa0a1a39	2026-08-21	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Redpharm Drug	58e6fd2f-e595-f788-e063-6394a90a0ea2	2026-08-13	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Preferred Pharmaceuticals, Inc	8c342c78-47fb-4f6b-9451-68b1f752555c	2026-08-12	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Preferred Pharmaceuticals Inc.	56192625-0564-4131-94b2-8b9c6a0b53b0	2026-08-12	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	REMEDYREPACK INC.	5f0759cc-c553-49b9-9049-80e713758958	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	REMEDYREPACK INC.	fba1ffe5-809a-495b-bf3e-f2099ac459f6	2026-07-28	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	REMEDYREPACK INC.	8f9fa2c8-4d25-48a8-9257-43c33d08e83a	2026-07-28	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	REMEDYREPACK INC.	b5972712-f735-46ed-a94a-b84668bb6a82	2026-07-24	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Chartwell RX, LLC	b0744674-ddf7-4022-be2f-2a22bef0d379	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Redpharm Drug	546c367a-c786-8326-e063-6294a90ae76c	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Proficient Rx LP	b8f797fb-979c-4eab-a3a6-ad4edcb9ff07	2026-06-01	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Bryant Ranch Prepack	609c3e26-9220-4f3c-b393-a2b41b68de6c	2026-03-12	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	QPharma Inc	8c11af69-146f-47ed-b12a-7b201fec7e50	2025-12-04	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	ceddc406-4a17-471f-917e-63b4b03779ea	2025-10-17	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	9bc7006d-a482-47c4-a138-5380ce927812	2025-10-16	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	4ad879d4-eb32-49f0-af73-c47fc7581936	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	450ad3aa-7c9e-497b-b00e-b1af0322f8d0	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	0151c742-7525-4707-af03-bd48d50cd586	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	281f9c32-e28a-46ae-9e4e-c2143aaa6c6b	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.