Home Applications 050609 Application 050609
Type NDA
Sponsor HOSPIRA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ERYTHROCIN ERYTHROMYCIN LACTOBIONATE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Yes Yes 002 ERYTHROCIN ERYTHROMYCIN LACTOBIONATE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050609-001 ERYTHROCIN ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 N050609-002 ERYTHROCIN ERYTHROMYCIN LACTOBIONATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050609-001 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.
Product history page 1 of 3 · 82 observed 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 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050609-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-09-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050609-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD 1986-09-24 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0409-6482 Erythrocin Lactobionate ERYTHROMYCIN LACTOBIONATE Hospira, Inc. NDA Current 0409-6482 Erythrocin Lactobionate ERYTHROMYCIN LACTOBIONATE Hospira, Inc. NDA Current 0409-6482 Erythrocin Lactobionate ERYTHROMYCIN LACTOBIONATE Hospira, Inc. NDA Current 0409-6482 Erythrocin Lactobionate ERYTHROMYCIN LACTOBIONATE Hospira, Inc. NDA Current