Application 050138

Type: NDA
Sponsor: KING PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BICILLIN C-R	PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE	INJECTABLE;INJECTION	300,000 UNITS/ML;300,000 UNITS/ML	Yes	Yes
002	BICILLIN C-R	PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE	INJECTABLE;INJECTION	150,000 UNITS/ML;150,000 UNITS/ML	Yes	No
003	BICILLIN C-R 900/300	PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE	INJECTABLE;INJECTION	900,000 UNITS/2ML;300,000 UNITS/2ML	Yes	Yes

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	RLD / RS
N050138-001	BICILLIN C-R	PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982
N050138-002	BICILLIN C-R	PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE	150,000 UNITS/ML;150,000 UNITS/ML	INJECTABLE / INJECTION	RLD, Approved before 1982
N050138-003	BICILLIN C-R 900/300	PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE	900,000 UNITS/2ML;300,000 UNITS/2ML	INJECTABLE / INJECTION	RLD, 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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050138-001	BICILLIN C-R	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050138-002	BICILLIN C-R	150,000 UNITS/ML;150,000 UNITS/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050138-003	BICILLIN C-R 900/300	900,000 UNITS/2ML;300,000 UNITS/2ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050138-001	BICILLIN C-R	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050138-002	BICILLIN C-R	150,000 UNITS/ML;150,000 UNITS/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050138-003	BICILLIN C-R 900/300	900,000 UNITS/2ML;300,000 UNITS/2ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050138-001	BICILLIN C-R	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050138-002	BICILLIN C-R	150,000 UNITS/ML;150,000 UNITS/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050138-003	BICILLIN C-R 900/300	900,000 UNITS/2ML;300,000 UNITS/2ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050138-001	BICILLIN C-R	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050138-002	BICILLIN C-R	150,000 UNITS/ML;150,000 UNITS/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050138-003	BICILLIN C-R 900/300	900,000 UNITS/2ML;300,000 UNITS/2ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050138-001	BICILLIN C-R	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050138-002	BICILLIN C-R	150,000 UNITS/ML;150,000 UNITS/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050138-003	BICILLIN C-R 900/300	900,000 UNITS/2ML;300,000 UNITS/2ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050138-001	BICILLIN C-R	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050138-002	BICILLIN C-R	150,000 UNITS/ML;150,000 UNITS/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050138-003	BICILLIN C-R 900/300	900,000 UNITS/2ML;300,000 UNITS/2ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050138-001	BICILLIN C-R	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050138-002	BICILLIN C-R	150,000 UNITS/ML;150,000 UNITS/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050138-003	BICILLIN C-R 900/300	900,000 UNITS/2ML;300,000 UNITS/2ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050138-001	BICILLIN C-R	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050138-002	BICILLIN C-R	150,000 UNITS/ML;150,000 UNITS/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050138-003	BICILLIN C-R 900/300	900,000 UNITS/2ML;300,000 UNITS/2ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050138-001	BICILLIN C-R	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050138-002	BICILLIN C-R	150,000 UNITS/ML;150,000 UNITS/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050138-003	BICILLIN C-R 900/300	900,000 UNITS/2ML;300,000 UNITS/2ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050138-001	BICILLIN C-R	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050138-002	BICILLIN C-R	150,000 UNITS/ML;150,000 UNITS/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050138-003	BICILLIN C-R 900/300	900,000 UNITS/2ML;300,000 UNITS/2ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050138-001	BICILLIN C-R	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050138-002	BICILLIN C-R	150,000 UNITS/ML;150,000 UNITS/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050138-003	BICILLIN C-R 900/300	900,000 UNITS/2ML;300,000 UNITS/2ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050138-001	BICILLIN C-R	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050138-002	BICILLIN C-R	150,000 UNITS/ML;150,000 UNITS/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050138-003	BICILLIN C-R 900/300	900,000 UNITS/2ML;300,000 UNITS/2ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050138-001	BICILLIN C-R	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050138-002	BICILLIN C-R	150,000 UNITS/ML;150,000 UNITS/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050138-003	BICILLIN C-R 900/300	900,000 UNITS/2ML;300,000 UNITS/2ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050138-001	BICILLIN C-R	300,000 UNITS/ML;300,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8072bd15b7f6…`

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 C-R 900/300	PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE	Pfizer Laboratories Div Pfizer Inc	ba7b9199-4710-4189-a85d-77ed75befe4d	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050138 application number: NDA050138 ndc (product): 60793-602
BICILLIN CR	PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE	Pfizer Laboratories Div Pfizer Inc	b5640fc6-76d8-428d-80e6-760d769af8bb	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050138 application number: NDA050138 ndc (product): 60793-600 ndc (product): 60793-601

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-1815	BICILLIN CR	penicillin G benzathine and penicillin G procaine	A-S Medication Solutions	NDA	Current
60793-600	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-600	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-600	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-600	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-600	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-600	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-600	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-601	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-601	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-601	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-601	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-601	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-601	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-601	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-602	BICILLIN C-R 900/300	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-602	BICILLIN C-R 900/300	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-602	BICILLIN C-R 900/300	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-602	BICILLIN C-R 900/300	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-602	BICILLIN C-R 900/300	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-602	BICILLIN C-R 900/300	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-602	BICILLIN C-R 900/300	penicillin G benzathine and penicillin G procaine	Pfizer Laboratories Div Pfizer Inc	NDA	Current
68258-8910	BICILLIN CR	penicillin G benzathine and penicillin G procaine	Dispensing Solutions, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65583	SUPPL	2020-12-14
65575	SUPPL	2020-12-11
65560	SUPPL	2020-12-10
65535	SUPPL	2020-12-09
59855	SUPPL	2019-08-27
59850	SUPPL	2019-08-27
58505	SUPPL	2019-05-01
58488	SUPPL	2019-04-30
56463	SUPPL	2018-11-15
56316	SUPPL	2018-11-06
50657	SUPPL	2017-12-12
38915	SUPPL	2015-10-15
29988	SUPPL	2015-10-14
38914	SUPPL	2014-05-12
29987	SUPPL	2014-04-29
17802	SUPPL	2012-09-11
29986	SUPPL	2012-09-07
29985	SUPPL	2009-12-31
17801	SUPPL	2009-12-22
7695	SUPPL	2005-11-18
29984	SUPPL	2004-12-29
29982	SUPPL	2004-05-28
29983	SUPPL	2002-04-29
7694	SUPPL	2002-04-29