FDA.reportPublic FDA data

BICILLIN CR

Product NDC
68258-8910
11-digit product format
682588910
Labeler code
68258
Product ID
68258-8910_b530e3ad-d9c7-4946-b19e-eef2ca16e407
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
penicillin G benzathine and penicillin G procaine
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Dispensing Solutions, Inc.
Application
NDA050138
Marketing category
NDA
Marketing start
1953-05-18
Marketing end
0000-00-00
Substance
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
Active strength
600000 [iU]/2mL; [iU]/2mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS],Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68258-8910-22019-11-27C16284748780-19855e2a2-4a58-60a7-e053-dbdaa90a05bdBicillin ® C-R (penicillin G benzathine and penicillin G procaine injectable suspension) Disposable Syringe for deep IM injection only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-8910-2BICILLIN CR2 mL in 1 SYRINGEINJECTION, SUSPENSION22

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
68258-8910BICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20131030_4bd2cd7a-327d-48ed-9e8b-e6a03e3188d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionUnitsStatus
68258-8910-2682588910022 mL in 1 SYRINGE2 mlHistorical