FDA.reportPublic FDA data

Lentocilin

Product NDC
84383-110
11-digit product format
843830110
Labeler code
84383
Product ID
84383-110_1a4e5124-618c-ce44-e063-6394a90a43e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin G Benzathin
Dosage form
INJECTION, POWDER, FOR SUSPENSION
Route
INTRAMUSCULAR
Labeler
LABORAT�RIOS ATRAL, S.A.
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start
2024-06-01
Substance
PENICILLIN G BENZATHINE
Active strength
1200000 U/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
Lentocilin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLIN G BENZATHINE1200000 U/4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2671687Internal RxNorm lookup
2684991Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a4e5124-618b-ce44-e063-6394a90a43e3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
ea092e41-01a8-4781-b199-b94446808a52Product name120190205
af7816cd-473e-4681-8ef5-5d4b569ced61Product name120151014
b37c02b5-6cf5-47fd-aab5-d510a02bbac0Product name120151014
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
0f47357f-4a94-e9f0-4fab-2eb6732c6263Product name120140508
11e45d82-8b7a-98b7-67b2-842a15f88536Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
6ccfe771-a97a-e261-3fb2-bf8e525d1fe0Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84383-110-01Lentocilin4 mL in 1 VIALINJECTION, POWDER, FOR SUSPENSIO41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84383-110-01EA - Each84383-110a1229663-f4c3-46b8-a428-7a86aa605a8f12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84383-110LENTOCILIN (PENICILLIN G BENZATHIN) INJECTION, POWDER, FOR SUSPENSION [LABORATÓRIOS ATRAL, S.A.]1Current NDC, 1 package rows20240614_1a4e5124-618b-ce44-e063-6394a90a43e3.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LentocilinPENICILLIN G BENZATHINLABORATRIOS ATRAL, S.A.1a4e5124-618b-ce44-e063-6394a90a43e32024-06-07Warnings, Adverse reactionsExact identifier
ndc (product): 84383-110

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2684991Lentocilin 1,200,000 UNT InjectionPSN1a4e5124-618b-ce44-e063-6394a90a43e31
2671687penicillin G benzathine 1,200,000 UNT InjectionPSN1a4e5124-618b-ce44-e063-6394a90a43e31
2684991penicillin G benzathine 1200000 UNT Injection [Lentocilin]SBD1a4e5124-618b-ce44-e063-6394a90a43e31
2671687penicillin G benzathine 1200000 UNT InjectionSCD1a4e5124-618b-ce44-e063-6394a90a43e31
2684991Lentocilin 1200000 UNT InjectionSY1a4e5124-618b-ce44-e063-6394a90a43e31
2671687penicillin G benzathine 1,200,000 UNT InjectionSY1a4e5124-618b-ce44-e063-6394a90a43e31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84383-110-01843830110014 mL in 1 VIAL (84383-110-01) 4 ml2024-06-01NoNoCurrent