FDA.reportPublic FDA data

BICILLIN L-A

Product NDC
50090-1016
11-digit product format
500901016
Labeler code
50090
Product ID
50090-1016_78cd2843-8c8f-43a1-b511-ba65823588ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
penicillin G benzathine
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
Application
NDA050141
Marketing category
NDA
Marketing start
1952-06-27
Substance
PENICILLIN G BENZATHINE
Active strength
1200000 [iU]/2mL
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 BENZATHINE1200000 [iU]/2mL

Harmonized Identifiers#

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

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
50090-1016-0BICILLIN L-A2 mL in 1 SYRINGEINJECTION, SUSPENSION218
50090-1016-0BICILLIN L-A10 in 1 PACKAGEINJECTION, SUSPENSION1018
50090-1016-1BICILLIN L-A2 mL in 1 SYRINGEINJECTION, SUSPENSION218
50090-1016-1BICILLIN L-A1 in 1 PACKAGEINJECTION, SUSPENSION118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1016-0ML - Milliliter50090-1016bbcd5ee2-74a3-4b56-b958-03da74c938f712018-10-11
50090-1016-1ML - Milliliter50090-10161014ab42-dbdf-409e-8112-60d53ff1c22412018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1016BICILLIN L-A (PENICILLIN G BENZATHINE) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 4 package rows20231025_a519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
731568BICILLIN L-A 1,200,000 UNT in 2 ML Prefilled SyringePSNa519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce18
731566BICILLIN L-A 600,000 UNT in 1 ML Prefilled SyringePSNa519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce18
731567penicillin G benzathine 1,200,000 UNT in 2 ML Prefilled SyringePSNa519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce18
731564penicillin G benzathine 600,000 UNT in 1 ML Prefilled SyringePSNa519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce18
7315661 ML penicillin G benzathine 600000 UNT/ML Prefilled Syringe [Bicillin L-A]SBDa519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce18
7315682 ML penicillin G benzathine 600000 UNT/ML Prefilled Syringe [Bicillin L-A]SBDa519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce18
7315641 ML penicillin G benzathine 600000 UNT/ML Prefilled SyringeSCDa519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce18
7315672 ML penicillin G benzathine 600000 UNT/ML Prefilled SyringeSCDa519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce18
731568Bicillin L-A 1,200,000 UNT per 2 ML Prefilled SyringeSYa519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce18
731566Bicillin L-A 600,000 UNT per 1 ML Prefilled SyringeSYa519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce18
731567penicillin G benzathine 1,200,000 UNT per 2 ML Prefilled SyringeSYa519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce18
731564penicillin G benzathine 600,000 UNT per 1 ML Prefilled SyringeSYa519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1016-05009010160010 SYRINGE in 1 PACKAGE (50090-1016-0) / 2 mL in 1 SYRINGE10 syringe2015-07-060000-00-00NoNoCurrent
50090-1016-1500901016011 SYRINGE in 1 PACKAGE (50090-1016-1) / 2 mL in 1 SYRINGE1 syringe2015-07-060000-00-00NoNoCurrent