FDA.reportPublic FDA data

Erythromycin Lactobionate

Product NDC
14789-116
11-digit product format
147890116
Labeler code
14789
Product ID
14789-116_c10e5a62-1ef9-47fa-becb-0d6a4f74177b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin Lactobionate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Nexus Pharamaceuticals Inc.
Application
ANDA215290
Marketing category
ANDA
Marketing start
2021-08-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct14789-116DDiscontinued by firm2026-08-03
excluded packagepackage14789-11614789-116-05DDiscontinued by firm2026-08-03

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
A215290-001ERYTHROMYCIN LACTOBIONATEERYTHROMYCIN LACTOBIONATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2022-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215290-001AP

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 22:54:322026-06A215290-001ERYTHROMYCIN LACTOBIONATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2022-02-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215290-001AP1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
14789-116-05EA - Each14789-1163532a696-9476-4608-ac4d-8856266840be12022-03-09
14789-116-07EA - Each14789-1169ec06f06-1956-4326-987c-b98f3bbd7a8212022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14789-116ERYTHROMYCIN LACTOBIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NEXUS PHARMACEUTICALS LLC]8Legacy NDC20241017_171b8b28-9da6-4bc6-85ea-f27fde5d5f10.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
14789-116-05147890116055 VIAL, GLASS in 1 BOX (14789-116-05) > 10 mL in 1 VIAL, GLASS (14789-116-07) 2021-08-010000-00-00NoNoCurrent