Application 050141

Type: NDA
Sponsor: KING PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BICILLIN L-A	PENICILLIN G BENZATHINE	INJECTABLE;INJECTION	600,000 UNITS/ML	Yes	Yes
003	BICILLIN L-A	PENICILLIN G BENZATHINE	INJECTABLE;INJECTION	300,000 UNITS/ML	Yes	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
N050141-001	BICILLIN L-A	PENICILLIN G BENZATHINE	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982
N050141-003	BICILLIN L-A	PENICILLIN G BENZATHINE	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050141-001	BC

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	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050141-001	BICILLIN L-A	600,000 UNITS/ML	INJECTABLE / INJECTION	BC	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050141-003	BICILLIN L-A	300,000 UNITS/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N050141-001	BC	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050141-001	BC	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050141-001	BC	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050141-001	BC	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050141-001	BC	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050141-001	BC	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050141-001	BC	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050141-001	BC	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050141-001	BC	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050141-001	BC	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050141-001	BC	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050141-001	BC	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050141-001	BC	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050141-001	BC	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050141-001	BC	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050141-001	BC	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050141-001	BC	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050141-001	BC	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050141-001	BC	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050141-001	BC	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050141-001	BC	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050141-001	BC	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050141-001	BC	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050141-001	BC	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050141-001	BC	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050141-001	BC	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050141-001	BC	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050141-001	BC	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050141-001	BC	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050141-001	BC	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050141-001	BC	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050141-001	BC	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050141-001	BC	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050141-001	BC	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050141-001	BC	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050141-001	BC	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050141-001	BC	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050141-001	BC	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050141-001	BC	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050141-001	BC	1	`cb3db0bc1861…`

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
BICILLIN L-A	PENICILLIN G BENZATHINE	Pfizer Laboratories Div Pfizer Inc	012d46f1-d0a0-4676-a879-cd320297ab16	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050141 application number: NDA050141 ndc (product): 60793-700 ndc (product): 60793-702 ndc (product): 60793-701
BICILLIN L-A	PENICILLIN G BENZATHINE	A-S Medication Solutions	a519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce	2023-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050141 application number: NDA050141 ndc (product): 50090-1666 ndc (product): 50090-1016

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-1016	BICILLIN L-A	penicillin G benzathine	A-S Medication Solutions	NDA	Current
50090-1016	BICILLIN L-A	penicillin G benzathine	A-S Medication Solutions	NDA	Current
50090-1016	BICILLIN L-A	penicillin G benzathine	A-S Medication Solutions	NDA	Current
50090-1016	BICILLIN L-A	penicillin G benzathine	A-S Medication Solutions	NDA	Current
50090-1016	BICILLIN L-A	penicillin G benzathine	A-S Medication Solutions	NDA	Current
50090-1666	BICILLIN L-A	penicillin G benzathine	A-S Medication Solutions	NDA	Current
50090-1666	BICILLIN L-A	penicillin G benzathine	A-S Medication Solutions	NDA	Current
50090-1666	BICILLIN L-A	penicillin G benzathine	A-S Medication Solutions	NDA	Current
60793-700	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-700	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-700	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-700	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-700	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-700	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-700	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-700	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-700	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-700	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-701	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-701	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-701	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-701	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-701	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-701	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-701	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-701	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-701	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-701	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-702	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-702	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-702	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-702	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-702	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-702	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-702	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-702	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-702	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-702	BICILLIN L-A	penicillin G benzathine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
68071-1824	BICILLIN L-A	penicillin G benzathine	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-1824	BICILLIN L-A	penicillin G benzathine	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-1824	BICILLIN L-A	penicillin G benzathine	NuCare Pharmaceuticals,Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67533	SUPPL	2021-05-18
67508	SUPPL	2021-05-17
65584	SUPPL	2020-12-14
65576	SUPPL	2020-12-11
65561	SUPPL	2020-12-10
65536	SUPPL	2020-12-09
58506	SUPPL	2019-05-03
58489	SUPPL	2019-04-30
56464	SUPPL	2018-11-15
56392	SUPPL	2018-11-08
50658	SUPPL	2017-12-12
17803	SUPPL	2015-10-15
29990	SUPPL	2015-10-14
38918	SUPPL	2014-05-12
29989	SUPPL	2014-04-29
38917	SUPPL	2012-09-11
7701	SUPPL	2012-09-07
7700	SUPPL	2009-12-31
38916	SUPPL	2009-12-22
7699	SUPPL	2005-11-18
7698	SUPPL	2002-04-29
7697	SUPPL	2002-04-29
7696	SUPPL	2002-03-01