Application 065448

Type: ANDA
Sponsor: ISTITUTO BIO ITA SPA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	INJECTABLE;INJECTION	5,000,000 UNITS/VIAL	No	No
002	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	INJECTABLE;INJECTION	20,000,000 UNITS/VIAL	No	No

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
A065448-001	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP		2009-08-18
A065448-002	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP		2009-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065448-001	AP
A065448-002	AP

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065448-001	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065448-002	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-08-18	`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	A065448-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065448-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065448-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065448-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065448-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065448-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065448-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065448-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065448-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065448-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065448-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065448-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065448-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065448-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065448-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065448-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065448-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065448-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065448-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065448-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065448-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065448-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065448-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065448-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065448-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065448-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065448-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065448-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065448-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065448-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065448-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065448-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065448-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065448-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065448-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065448-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065448-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065448-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065448-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065448-002	AP	1	`782e0a99824c…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	HF Acquisition Co LLC, DBA HealthFirst	56ab659e-ad28-028f-e063-6394a90a6943	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065448 application number: ANDA065448
Penicillin G Potassium	PENICILLIN G POTASSIUM	WG Critical Care, LLC	e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065448 application number: ANDA065448
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	HF Acquisition Co LLC, DBA HealthFirst	50c7500f-be06-01af-e063-6294a90a0135	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065448 application number: ANDA065448
Penicillin G Potassium	PENICILLIN G POTASSIUM	Avenacy Inc.	969a421e-37d8-499e-9e89-67e210bd5d9d	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065448 application number: ANDA065448
Penicillin G Potassium	PENICILLIN G POTASSIUM	Athenex Pharmaceutical Division, LLC.	1442486a-05d6-4dce-8b95-857a30f478c2	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065448 application number: ANDA065448 ndc (product): 70860-126 ndc (product): 70860-127
Penicillin G Potassium	PENICILLIN G POTASSIUM	Sagent Pharmaceuticals	fb2f3afe-0072-4383-bad8-9da9e94db4f2	2024-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065448 application number: ANDA065448
Penicillin G Potassium	PENICILLIN G POTASSIUM	NorthStar Rx, LLC	8732b7ff-2e47-4f99-aadf-81861b431f4f	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065448 application number: ANDA065448

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70860-126	Penicillin G Potassium	penicillin g potassium	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-127	Penicillin G Potassium	penicillin g potassium	Athenex Pharmaceutical Division, LLC.	ANDA	Current