Home NDC 68083-513 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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216761-001 ERYTHROMYCIN LACTOBIONATE ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2024-11-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216761-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A216761-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2024-11-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216761-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2024-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216761-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2024-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216761-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2024-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216761-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2024-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216761-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2024-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216761-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2024-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216761-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2024-11-19 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216761-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2024-11-19 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base erythromycin lactobionate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERYTHROMYCIN LACTOBIONATE 500 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 33H58I7GLQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1668264 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68083-513-01 erythromycin lactobionate 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 10 4 68083-513-10 erythromycin lactobionate 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-513 ERYTHROMYCIN LACTOBIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] 4 Current NDC, 2 package rows 20241123_c6f9565b-6d9d-40e3-87f8-9f38ede9173a.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68083-513-01 68083051301 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 68083-513-10 68083051310 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-513-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-513-01) 2024-11-19 No No Current