Application 065149

Type: ANDA
Sponsor: HANFORD GC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	INJECTABLE;INJECTION	1,000,000 UNITS/VIAL	No	No
002	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	INJECTABLE;INJECTION	5,000,000 UNITS/VIAL	No	No
003	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 42.

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	TE codes	Approval date
A065149-001	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23
A065149-002	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23
A065149-003	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065149-002	AP
A065149-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065149-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065149-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2009-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065149-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		2009-07-23	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065149-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065149-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065149-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065149-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065149-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065149-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065149-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065149-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065149-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065149-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065149-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065149-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065149-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065149-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065149-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065149-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065149-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065149-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065149-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065149-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065149-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065149-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065149-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065149-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065149-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065149-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065149-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065149-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065149-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065149-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065149-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065149-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065149-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065149-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065149-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065149-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065149-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065149-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065149-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065149-003	AP	1	`bb7c543d1eb4…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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): 065149 application number: ANDA065149 ndc (product): 44567-311 ndc (product): 44567-312 ndc (product): 44567-310

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44567-310	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current
44567-310	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current
44567-310	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current
44567-310	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current
44567-310	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current
44567-311	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current
44567-311	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current
44567-311	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current
44567-311	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current
44567-311	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current
44567-312	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current
44567-312	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current
44567-312	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current
44567-312	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current
44567-312	Penicillin G Potassium	Penicillin G Potassium	WG Critical Care, LLC	ANDA	Current