Home NDC 51754-7000-3 Erythromycin Lactobionate
Product NDC 51754-7000
Requested package NDC 51754-7000-3
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# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 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