Home NDC 0409-6476 Erythrocin Lactobionate
Product NDC 0409-6476
11-digit product format 004096476
Labeler code 0409
Product ID 0409-6476_ffa36ce2-7c68-4981-860c-f1538a2f9a63
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ERYTHROMYCIN LACTOBIONATE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA062638
Marketing category ANDA
Marketing start 2006-03-16
Marketing end 0000-00-00
Substance ERYTHROMYCIN LACTOBIONATE
Active strength 500 mg/100mL
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A062638-001 ERYTHROCIN ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 A062638-002 ERYTHROCIN ERYTHROMYCIN LACTOBIONATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062638-001 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 · 86 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 2026-09-14 22:38:34 2026-08 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062638-001 ERYTHROCIN EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1986-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062638-002 ERYTHROCIN EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1986-10-31 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-09-29 23:25 UTC 2022-09 A062638-001 AP 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A062638-001 AP 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A062638-001 AP 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-6476-44 Erythrocin Lactobionate 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 24 0409-6476-54 Erythrocin Lactobionate 100 mL in 1 VIAL, PATENT DELIVERY SYSTEM INJECTION, POWDER, LYOPHILIZED, 100 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ERYTHROMYCIN LACTOBIONATE ACTIVE INGREDIENT 33H58I7GLQ ERYTHROCIN LACTOBIONATE (ERYTHROMYCIN LACTOBIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 13 ERYTHROMYCIN ACTIVE MOIETY 63937KV33D ERYTHROCIN LACTOBIONATE (ERYTHROMYCIN LACTOBIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-6476 ERYTHROCIN LACTOBIONATE (ERYTHROMYCIN LACTOBIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 23 Legacy NDC, 2 package rows 20241207_9231d2fa-2e91-4eef-afa3-7515bc34df0b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0409-6476-44 00409647644 10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-6476-44) > 100 mL in 1 VIAL, PATENT DELIVERY SYSTEM (0409-6476-54) 2006-03-16 0000-00-00 No No Current 0409-6476-54 00409647654 100 mL in 1 VIAL, PATENT DELIVERY SYSTEM 100 ml Historical