BICILLIN C-R 900/300

Product NDC
60793-602
11-digit product format
607930602
Labeler code
60793
Product ID
60793-602_195a9cf6-47b7-4564-a39e-7b2396db4229
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
penicillin G benzathine and penicillin G procaine
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA050138
Marketing category
NDA
Marketing start
1953-05-18
Substance
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
Active strength
900000; 300000 [iU]/2mL; [iU]/2mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050138-001BICILLIN C-RPENICILLIN G BENZATHINE; PENICILLIN G PROCAINE300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982
N050138-002BICILLIN C-RPENICILLIN G BENZATHINE; PENICILLIN G PROCAINE150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 1982
N050138-003BICILLIN C-R 900/300PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19828072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
BICILLIN C-R 900/300
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLIN G BENZATHINE900000 [iU]/2mL
PENICILLIN G PROCAINE300000 [iU]/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RIT82F58GKInternal UNII lookup
17R794ESYNInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
836306Internal RxNorm lookup
836307Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ba7b9199-4710-4189-a85d-77ed75befe4dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea092e41-01a8-4781-b199-b94446808a52Product name120190205
af7816cd-473e-4681-8ef5-5d4b569ced61Product name120151014
b37c02b5-6cf5-47fd-aab5-d510a02bbac0Product name120151014
0f47357f-4a94-e9f0-4fab-2eb6732c6263Product name120140508
11e45d82-8b7a-98b7-67b2-842a15f88536Product name120140508
6ccfe771-a97a-e261-3fb2-bf8e525d1fe0Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60793-602-02BICILLIN C-R 900/3002 mL in 1 SYRINGEINJECTION, SUSPENSION231
60793-602-10BICILLIN C-R 900/30010 in 1 PACKAGEINJECTION, SUSPENSION1031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60793-602-02ML - Milliliter60793-602b817c2e5-42cd-4af7-bddd-9f8bbf1e314712014-11-05
60793-602-10ML - Milliliter60793-6025bf2c7fa-3de4-483e-9817-817cfb3f671912012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60793-602BICILLIN C-R 900/300 (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]31Current NDC, Legacy NDC, 2 package rows20240606_ba7b9199-4710-4189-a85d-77ed75befe4d.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BICILLIN C-R 900/300PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINEPfizer Laboratories Div Pfizer Incba7b9199-4710-4189-a85d-77ed75befe4d2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050138
application number: NDA050138
ndc (product): 60793-602
BICILLIN CRPENICILLIN G BENZATHINE AND PENICILLIN G PROCAINEPfizer Laboratories Div Pfizer Incb5640fc6-76d8-428d-80e6-760d769af8bb2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050138
application number: NDA050138

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836307BICILLIN C-R 900/300 1,200,000 UNT in 2 ML Prefilled SyringePSNba7b9199-4710-4189-a85d-77ed75befe4d31
836306penicillin G benzathine / penicillin G procaine 1,200,000 UNT (900,000 UNT/ 300,000 UNT) in 2 ML Prefilled SyringePSNba7b9199-4710-4189-a85d-77ed75befe4d31
8363072 ML penicillin G benzathine 450000 UNT/ML / penicillin G procaine 150000 UNT/ML Prefilled Syringe [Bicillin]SBDba7b9199-4710-4189-a85d-77ed75befe4d31
8363062 ML penicillin G benzathine 450000 UNT/ML / penicillin G procaine 150000 UNT/ML Prefilled SyringeSCDba7b9199-4710-4189-a85d-77ed75befe4d31
8363072 ML Bicillin C-R 900/300 Prefilled SyringeSYba7b9199-4710-4189-a85d-77ed75befe4d31
836307Bicillin C-R 900/300 (penicillin G benzathine 900,000 UNT / penicillin G procaine 300,000 UNT) per 2 ML Prefilled SyringeSYba7b9199-4710-4189-a85d-77ed75befe4d31
836306penicillin G benzathine 900,000 UNT / penicillin G procaine 300,000 UNT per 2 ML Prefilled SyringeSYba7b9199-4710-4189-a85d-77ed75befe4d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60793-602-02607930602022 mL in 1 SYRINGE2 mlHistorical
60793-602-106079306021010 SYRINGE in 1 PACKAGE (60793-602-10) / 2 mL in 1 SYRINGE (60793-602-02) 10 syringe1953-05-180000-00-00NoNoCurrent