Home NDC 51754-7000 Erythromycin Lactobionate
Product NDC 51754-7000
11-digit product format 517547000
Labeler code 51754
Product ID 51754-7000_e69b3024-f4bd-456e-8c74-2f9bc33739c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ERYTHROMYCIN LACTOBIONATE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Exela Pharma Sciences, LLC
Application ANDA211086
Marketing category ANDA
Marketing start 2021-03-15
Marketing end 0000-00-00
Substance ERYTHROMYCIN LACTOBIONATE
Active strength 500 mg/10mL
Pharmacologic classes Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 2 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 51754-7000 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51754-7000 51754-7000-3 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211086-001 ERYTHROMYCIN LACTOBIONATE ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17
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 2026-02-19 14:30 UTC 2026-02 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2020-09-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211086-001 ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2020-09-17 a50c72e98297…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51754-7000 ERYTHROMYCIN LACTOBIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EXELA PHARMA SCIENCES, LLC] 1 Legacy NDC 20210316_e69b3024-f4bd-456e-8c74-2f9bc33739c9.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51754-7000-3 51754700003 10 VIAL, SINGLE-DOSE in 1 PACKAGE (51754-7000-3) > 10 mL in 1 VIAL, SINGLE-DOSE 2021-03-15 0000-00-00 No No Current