Penicillin V Potassium

Product NDC: 68071-1806
11-digit product format: 680711806
Labeler code: 68071
Product ID: 68071-1806_51f3d155-3714-4c40-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin V Potassium
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA060456
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 0000-00-00
Substance: PENICILLIN V POTASSIUM
Active strength: 125 mg/5mL
Pharmacologic classes: Penicillins [CS],Penicillin-class Antibacterial [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-1806		D	Discontinued by firm		2026-08-03
excluded package	package	68071-1806	68071-1806-1	D	Discontinued by firm		2026-08-03

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
A060456-001	PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982
A060456-002	PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, 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 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	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A060456-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060456-002	AA	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	A060456-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A060456-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A060456-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A060456-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A060456-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A060456-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A060456-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A060456-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A060456-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A060456-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A060456-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A060456-002	AA	1	`ea99ee380514…`

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 · 6 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): 060456 application number: ANDA060456
Penicillin V Potassium	PENICILLIN V POTASSIUM	Preferred Pharmaceuticals, Inc	8c342c78-47fb-4f6b-9451-68b1f752555c	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	55a44735-6d6e-3012-e054-00144ff8d46c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	ded0ee2e-56ae-41fe-949c-177614cd8e1f	2023-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456
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): 060456 application number: ANDA060456
Penicillin V Potassium	PENICILLIN V POTASSIUM	Proficient Rx LP	316aa904-09f1-4a8e-9adf-93cfc14f9a0a	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PENICILLIN V POTASSIUM TABLETS, USP PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USP 1172 1174 4125 4127	NuCare Pharmaceuticals, Inc.	2017-06-14	HUMAN PRESCRIPTION DRUG LABEL	1

Penicillin V Potassium

NDC auxiliary status#

Orange Book products#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#