Erythrocin Lactobionate

Product NDC
0409-6476
11-digit product format
004096476
Labeler code
0409
Product ID
0409-6476_161a5404-c197-4b8b-b525-9351dd8fe2f1
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
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-6476DDiscontinued by firm2026-08-03
excluded packagepackage0409-64760409-6476-44DDiscontinued by firm2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062638-001ERYTHROCINERYTHROMYCIN LACTOBIONATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-31
A062638-002ERYTHROCINERYTHROMYCIN LACTOBIONATEEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A062638-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062638-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1986-10-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A062638-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTION1986-10-31782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062638-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062638-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062638-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062638-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062638-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062638-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062638-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062638-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062638-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062638-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062638-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062638-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062638-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062638-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062638-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062638-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062638-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062638-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062638-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062638-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062638-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A062638-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062638-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062638-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062638-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A062638-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062638-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062638-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062638-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062638-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062638-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062638-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062638-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062638-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062638-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062638-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062638-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062638-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062638-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062638-001AP1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-6476-44Erythrocin Lactobionate10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,1024
0409-6476-54Erythrocin Lactobionate100 mL in 1 VIAL, PATENT DELIVERY SYSTEMINJECTION, POWDER, LYOPHILIZED,10024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6476-44EA - Each0409-64768107358e-99a9-41d0-98cf-db5cfd461e0712012-07-24
0409-6476-54EA - Each0409-64760dd43e9e-c44f-4efa-9062-af19a3b3a09012018-10-11

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-6476ERYTHROCIN LACTOBIONATE (ERYTHROMYCIN LACTOBIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]23Current NDC, Legacy NDC, 2 package rows20241207_9231d2fa-2e91-4eef-afa3-7515bc34df0b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-6476-440040964764410 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-6476-44) / 100 mL in 1 VIAL, PATENT DELIVERY SYSTEM (0409-6476-54) 2006-03-160000-00-00NoNoCurrent
0409-6476-5400409647654100 mL in 1 VIAL, PATENT DELIVERY SYSTEM100 mlHistorical