Application 060456

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PENICILLIN-VK	PENICILLIN V POTASSIUM	FOR SOLUTION;ORAL	EQ 125MG BASE/5ML	No	No
002	PENICILLIN-VK	PENICILLIN V POTASSIUM	FOR SOLUTION;ORAL	EQ 250MG BASE/5ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982	`caaa826d4ba7…`
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…`

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#

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 · 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	Preferred Pharmaceuticals, Inc	8c342c78-47fb-4f6b-9451-68b1f752555c	2026-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456 ndc (product): 68788-9853 ndc (product): 68788-9852
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	NuCare Pharmaceuticals,Inc.	55a44735-6d6e-3012-e054-00144ff8d46c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456 ndc (product): 68071-1820
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 ndc (product): 50090-0409
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 ndc (product): 0093-4125 ndc (product): 0093-4127
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 ndc (product): 63187-533

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-4125	Penicillin V Potassium	Penicillin V Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4125	Penicillin V Potassium	Penicillin V Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4125	Penicillin V Potassium	Penicillin V Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4127	Penicillin V Potassium	Penicillin V Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4127	Penicillin V Potassium	Penicillin V Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-4127	Penicillin V Potassium	Penicillin V Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
21695-559	Penicillin V Potassium	Penicillin V Potassium	Rebel Distributors Corp	ANDA	Current
21695-772	Penicillin V Potassium	Penicillin V Potassium	Rebel Distributors Corp	ANDA	Current
50090-0408	Penicillin V Potassium	Penicillin V Potassium	A-S Medication Solutions	ANDA	Current
50090-0409	Penicillin V Potassium	Penicillin V Potassium	A-S Medication Solutions	ANDA	Current
53002-2130	Penicillin V Potassium	Penicillin V Potassium	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-2130	Penicillin V Potassium	Penicillin V Potassium	RPK Pharmaceuticals, Inc.	ANDA	Current
63187-533	Penicillin V Potassium	Penicillin V Potassium	Proficient Rx LP	ANDA	Current
63187-533	Penicillin V Potassium	Penicillin V Potassium	Proficient Rx LP	ANDA	Current
68071-1778	Penicillin V Potassium	Penicillin V Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1806	Penicillin V Potassium	Penicillin V Potassium	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1820	Penicillin V Potassium	Penicillin V Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1820	Penicillin V Potassium	Penicillin V Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1820	Penicillin V Potassium	Penicillin V Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9852	Penicillin V Potassium	Penicillin V Potassium	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9852	Penicillin V Potassium	Penicillin V Potassium	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9852	Penicillin V Potassium	Penicillin V Potassium	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9852	Penicillin V Potassium	Penicillin V Potassium	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9853	Penicillin V Potassium	Penicillin V Potassium	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9853	Penicillin V Potassium	Penicillin V Potassium	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9853	Penicillin V Potassium	Penicillin V Potassium	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9853	Penicillin V Potassium	Penicillin V Potassium	Preferred Pharmaceuticals, Inc	ANDA	Current