Application 065079

Type: ANDA
Sponsor: SANDOZ

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POTASSIUM	INJECTABLE;INJECTION	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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 1.

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
A065079-001	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30
A065079-002	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30
A065079-003	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065079-002	AP
A065079-003	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 · 123 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	A065079-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065079-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065079-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065079-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065079-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065079-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065079-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065079-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065079-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065079-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065079-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065079-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065079-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065079-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065079-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065079-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065079-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065079-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065079-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065079-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065079-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065079-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065079-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065079-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065079-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065079-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065079-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065079-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065079-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065079-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065079-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065079-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065079-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065079-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065079-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065079-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065079-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065079-002	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065079-003	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	2002-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065079-001	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		2002-08-30	`8072bd15b7f6…`

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	A065079-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065079-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065079-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065079-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065079-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065079-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065079-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065079-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065079-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065079-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065079-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065079-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065079-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065079-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065079-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065079-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065079-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065079-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065079-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065079-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065079-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065079-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065079-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065079-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065079-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065079-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065079-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065079-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065079-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065079-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065079-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065079-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065079-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065079-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065079-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065079-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065079-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065079-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065079-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065079-003	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUFFERED PENICILLIN G POTASSIUM	BUFFERED PENICILLIN G POTASSIUM	HF Acquisition Co LLC, DBA HealthFirst	9d4a3acc-6464-7d0d-e053-2a95a90a07e0	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065079 application number: ANDA065079 ndc (product): 51662-1436
Penicillin G Potassium	PENICILLIN G POTASSIUM	Sandoz Inc	91950983-4884-40d1-abd8-bcc953d61b7f	2020-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065079 application number: ANDA065079 ndc (product): 0781-6135 ndc (product): 0781-6136

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-6135	Penicillin G Potassium	Penicillin G Potassium	Sandoz Inc	ANDA	Current
0781-6135	Penicillin G Potassium	Penicillin G Potassium	Sandoz Inc	ANDA	Current
0781-6135	Penicillin G Potassium	Penicillin G Potassium	Sandoz Inc	ANDA	Current
0781-6136	Penicillin G Potassium	Penicillin G Potassium	Sandoz Inc	ANDA	Current
0781-6136	Penicillin G Potassium	Penicillin G Potassium	Sandoz Inc	ANDA	Current
0781-6136	Penicillin G Potassium	Penicillin G Potassium	Sandoz Inc	ANDA	Current
51662-1436	BUFFERED PENICILLIN G POTASSIUM	BUFFERED PENICILLIN G POTASSIUM	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1436	BUFFERED PENICILLIN G POTASSIUM	BUFFERED PENICILLIN G POTASSIUM	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current