FDA.reportPublic FDA data

BICILLIN L-A

Product NDC
60793-702
11-digit product format
607930702
Labeler code
60793
Product ID
60793-702_4b3694af-9d77-487f-8838-b75aec6636da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
penicillin G benzathine
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA050141
Marketing category
NDA
Marketing start
1952-06-27
Substance
PENICILLIN G BENZATHINE
Active strength
2400000 [iU]/4mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], 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 L-A
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLIN G BENZATHINE2400000 [iU]/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRIT82F58GK
Rxcui731564, 731566, 731567, 731568, 731570, 731571

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
60793-702-04BICILLIN L-A4 mL in 1 SYRINGEINJECTION, SUSPENSION434
60793-702-10BICILLIN L-A10 in 1 PACKAGEINJECTION, SUSPENSION1034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60793-702-04ML - Milliliter60793-70250a0c24c-f0b9-41f3-94bb-36711ff3e72f12014-08-01
60793-702-10ML - Milliliter60793-702b9d4e84d-5459-4ef5-8fc3-b8886ecfa85d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PENICILLIN G BENZATHINEACTIVE INGREDIENTRIT82F58GKBICILLIN L-A (PENICILLIN G BENZATHINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]13
PENICILLIN GACTIVE MOIETYQ42T66VG0CBICILLIN L-A (PENICILLIN G BENZATHINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]13
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XBICILLIN L-A (PENICILLIN G BENZATHINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]13
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62BICILLIN L-A (PENICILLIN G BENZATHINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBICILLIN L-A (PENICILLIN G BENZATHINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]13
POVIDONESINACTIVE INGREDIENTFZ989GH94EBICILLIN L-A (PENICILLIN G BENZATHINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]13
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBICILLIN L-A (PENICILLIN G BENZATHINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]13
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBICILLIN L-A (PENICILLIN G BENZATHINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]13
WATERINACTIVE INGREDIENT059QF0KO0RBICILLIN L-A (PENICILLIN G BENZATHINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60793-702BICILLIN L-A (PENICILLIN G BENZATHINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]34Current NDC, Legacy NDC, 2 package rows20240713_012d46f1-d0a0-4676-a879-cd320297ab16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
731568BICILLIN L-A 1,200,000 UNT in 2 ML Prefilled SyringePSN012d46f1-d0a0-4676-a879-cd320297ab1634
731571BICILLIN L-A 2,400,000 UNT in 4 ML Prefilled SyringePSN012d46f1-d0a0-4676-a879-cd320297ab1634
731566BICILLIN L-A 600,000 UNT in 1 ML Prefilled SyringePSN012d46f1-d0a0-4676-a879-cd320297ab1634
731567penicillin G benzathine 1,200,000 UNT in 2 ML Prefilled SyringePSN012d46f1-d0a0-4676-a879-cd320297ab1634
731570penicillin G benzathine 2,400,000 UNT in 4 ML Prefilled SyringePSN012d46f1-d0a0-4676-a879-cd320297ab1634
731564penicillin G benzathine 600,000 UNT in 1 ML Prefilled SyringePSN012d46f1-d0a0-4676-a879-cd320297ab1634
7315661 ML penicillin G benzathine 600000 UNT/ML Prefilled Syringe [Bicillin L-A]SBD012d46f1-d0a0-4676-a879-cd320297ab1634
7315682 ML penicillin G benzathine 600000 UNT/ML Prefilled Syringe [Bicillin L-A]SBD012d46f1-d0a0-4676-a879-cd320297ab1634
7315714 ML penicillin G benzathine 600000 UNT/ML Prefilled Syringe [Bicillin L-A]SBD012d46f1-d0a0-4676-a879-cd320297ab1634
7315641 ML penicillin G benzathine 600000 UNT/ML Prefilled SyringeSCD012d46f1-d0a0-4676-a879-cd320297ab1634
7315672 ML penicillin G benzathine 600000 UNT/ML Prefilled SyringeSCD012d46f1-d0a0-4676-a879-cd320297ab1634
7315704 ML penicillin G benzathine 600000 UNT/ML Prefilled SyringeSCD012d46f1-d0a0-4676-a879-cd320297ab1634
731568Bicillin L-A 1,200,000 UNT per 2 ML Prefilled SyringeSY012d46f1-d0a0-4676-a879-cd320297ab1634
731571Bicillin L-A 2,400,000 UNT per 4 ML Prefilled SyringeSY012d46f1-d0a0-4676-a879-cd320297ab1634
731566Bicillin L-A 600,000 UNT per 1 ML Prefilled SyringeSY012d46f1-d0a0-4676-a879-cd320297ab1634
731567penicillin G benzathine 1,200,000 UNT per 2 ML Prefilled SyringeSY012d46f1-d0a0-4676-a879-cd320297ab1634
731570penicillin G benzathine 2,400,000 UNT per 4 ML Prefilled SyringeSY012d46f1-d0a0-4676-a879-cd320297ab1634
731564penicillin G benzathine 600,000 UNT per 1 ML Prefilled SyringeSY012d46f1-d0a0-4676-a879-cd320297ab1634

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60793-702-04607930702044 mL in 1 SYRINGE4 mlHistorical
60793-702-106079307021010 SYRINGE in 1 PACKAGE (60793-702-10) / 4 mL in 1 SYRINGE (60793-702-04) 10 syringe1952-06-270000-00-00NoNoCurrent