FDA.reportPublic FDA data

erythromycin lactobionate

Product NDC
68083-513
11-digit product format
680830513
Labeler code
68083
Product ID
68083-513_62d03a60-5432-4fa9-a4bb-e14276b78b47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
erythromycin lactobionate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA216761
Marketing category
ANDA
Marketing start
2024-11-19
Substance
ERYTHROMYCIN LACTOBIONATE
Active strength
500 mg/10mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216761-001ERYTHROMYCIN LACTOBIONATEERYTHROMYCIN LACTOBIONATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2024-11-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A216761-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A216761-001ERYTHROMYCIN LACTOBIONATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2024-11-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216761-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Erythromycin LactobionateERYTHROMYCIN LACTOBIONATEArmas Pharmaceuticals Inc.ca65a48f-5fe6-4b31-8359-51dbc31f6d4e2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216761
application number: ANDA216761
erythromycin lactobionateERYTHROMYCIN LACTOBIONATEGland Pharma Limitedc6f9565b-6d9d-40e3-87f8-9f38ede9173a2024-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216761
application number: ANDA216761
ndc (product): 68083-513

Additional Listing Data#

Finished product
Yes
Brand name base
erythromycin lactobionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERYTHROMYCIN LACTOBIONATE500 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33H58I7GLQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1668264Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c6f9565b-6d9d-40e3-87f8-9f38ede9173aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-513-01erythromycin lactobionate10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,104
68083-513-10erythromycin lactobionate10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-513ERYTHROMYCIN LACTOBIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]4Current NDC, 2 package rows20241123_c6f9565b-6d9d-40e3-87f8-9f38ede9173a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1668264erythromycin lactobionate 500 MG InjectionPSNc6f9565b-6d9d-40e3-87f8-9f38ede9173a4
1668264erythromycin lactobionate 500 MG InjectionSCDc6f9565b-6d9d-40e3-87f8-9f38ede9173a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-513-016808305130110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
68083-513-106808305131010 VIAL, SINGLE-DOSE in 1 CARTON (68083-513-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-513-01) 2024-11-19NoNoCurrent