FDA.reportPublic FDA data

BICILLIN CR

Product NDC
60793-601
11-digit product format
607930601
Labeler code
60793
Product ID
60793-601_b5d01048-1d94-4a82-9a67-fdddd23235a9
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
600000; 600000 [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

Additional Listing Data#

Finished product
Yes
Brand name base
BICILLIN CR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLIN G BENZATHINE600000 [iU]/2mL
PENICILLIN G PROCAINE600000 [iU]/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRIT82F58GK, 17R794ESYN
Rxcui731538, 731541

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
60793-601-02BICILLIN CR2 mL in 1 SYRINGEINJECTION, SUSPENSION227
60793-601-10BICILLIN CR10 in 1 PACKAGEINJECTION, SUSPENSION1027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60793-601-02ML - Milliliter60793-601e32e9bea-25c8-426f-87a4-8a5dc906f64212015-03-03
60793-601-10ML - Milliliter60793-6016cf67928-cdb5-4bc9-8ff0-d37c9fdaaee412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PENICILLIN G BENZATHINEACTIVE INGREDIENTRIT82F58GKBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]11
PENICILLIN G PROCAINEACTIVE INGREDIENT17R794ESYNBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]11
PENICILLIN GACTIVE MOIETYQ42T66VG0CBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]11
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]11
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62BICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]11
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]11
POVIDONESINACTIVE INGREDIENTFZ989GH94EBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]11
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]11
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]11
WATERINACTIVE INGREDIENT059QF0KO0RBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]11
PENICILLIN G BENZATHINEACTIVE INGREDIENTRIT82F58GKBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]2
PENICILLIN G PROCAINEACTIVE INGREDIENT17R794ESYNBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]2
PENICILLIN GACTIVE MOIETYQ42T66VG0CBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]2
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62BICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RBICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60793-601BICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]27Current NDC, Legacy NDC, 2 package rows20240606_b5640fc6-76d8-428d-80e6-760d769af8bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
731541BICILLIN C-R 1,200,000 UNT in 2 ML Prefilled SyringePSNb5640fc6-76d8-428d-80e6-760d769af8bb27
731538penicillin G benzathine / penicillin G procaine 1,200,000 UNT (600,000 UNT/ 600,000 UNT) in 2 ML Prefilled SyringePSNb5640fc6-76d8-428d-80e6-760d769af8bb27
7315412 ML penicillin G benzathine 300000 UNT/ML / penicillin G procaine 300000 UNT/ML Prefilled Syringe [Bicillin]SBDb5640fc6-76d8-428d-80e6-760d769af8bb27
7315382 ML penicillin G benzathine 300000 UNT/ML / penicillin G procaine 300000 UNT/ML Prefilled SyringeSCDb5640fc6-76d8-428d-80e6-760d769af8bb27
731541Bicillin C-R (penicillin G benzathine 600,000 UNT / penicillin G procaine 600,000 UNT) per 2 ML Prefilled SyringeSYb5640fc6-76d8-428d-80e6-760d769af8bb27
731541Bicillin C-R 1.2 Million per 2 ML (600,000 UNT / 600,000 UNT) Prefilled SyringeSYb5640fc6-76d8-428d-80e6-760d769af8bb27
731538penicillin G benzathine 600,000 UNT / penicillin G procaine 600000 UNT per 2 ML Prefilled SyringeSYb5640fc6-76d8-428d-80e6-760d769af8bb27
731541BICILLIN C-R 1,200,000 UNT in 2 ML Prefilled SyringePSN4bd2cd7a-327d-48ed-9e8b-e6a03e3188d92
731538penicillin G benzathine / penicillin G procaine 1,200,000 UNT (600,000 UNT/ 600,000 UNT) in 2 ML Prefilled SyringePSN4bd2cd7a-327d-48ed-9e8b-e6a03e3188d92
7315412 ML penicillin G benzathine 300000 UNT/ML / penicillin G procaine 300000 UNT/ML Prefilled Syringe [Bicillin]SBD4bd2cd7a-327d-48ed-9e8b-e6a03e3188d92
7315382 ML penicillin G benzathine 300000 UNT/ML / penicillin G procaine 300000 UNT/ML Prefilled SyringeSCD4bd2cd7a-327d-48ed-9e8b-e6a03e3188d92
731541Bicillin C-R (penicillin G benzathine 600,000 UNT / penicillin G procaine 600,000 UNT) per 2 ML Prefilled SyringeSY4bd2cd7a-327d-48ed-9e8b-e6a03e3188d92
731541Bicillin C-R 1.2 Million per 2 ML (600,000 UNT / 600,000 UNT) Prefilled SyringeSY4bd2cd7a-327d-48ed-9e8b-e6a03e3188d92
731538penicillin G benzathine 600,000 UNT / penicillin G procaine 600000 UNT per 2 ML Prefilled SyringeSY4bd2cd7a-327d-48ed-9e8b-e6a03e3188d92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60793-601-02607930601022 mL in 1 SYRINGE2 mlHistorical
60793-601-106079306011010 SYRINGE in 1 PACKAGE (60793-601-10) / 2 mL in 1 SYRINGE (60793-601-02) 10 syringe1953-05-180000-00-00NoNoCurrent