Erythrocin Lactobionate

Product NDC
0409-6482
11-digit product format
004096482
Labeler code
0409
Product ID
0409-6482_129ba067-a214-45c6-8c39-cafc82a32546
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ERYTHROMYCIN LACTOBIONATE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA050609
Marketing category
NDA
Marketing start
2005-05-25
Substance
ERYTHROMYCIN LACTOBIONATE
Active strength
500 mg/10mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
N050609-001ERYTHROCINERYTHROMYCIN LACTOBIONATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-24
N050609-002ERYTHROCINERYTHROMYCIN LACTOBIONATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N050609-001AP

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 UTC2026-02N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050609-001ERYTHROCINEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1986-09-24782e0a99824c…
2021-12-28 21:50 UTC2021-12N050609-002ERYTHROCINEQ 1GM BASE/VIALINJECTABLE / INJECTIONRLD1986-09-24782e0a99824c…

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 UTC2026-02N050609-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050609-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050609-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050609-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050609-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050609-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050609-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050609-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050609-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050609-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050609-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050609-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050609-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050609-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050609-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050609-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050609-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050609-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050609-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050609-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050609-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N050609-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050609-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050609-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050609-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N050609-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050609-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050609-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050609-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050609-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050609-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050609-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050609-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050609-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N050609-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N050609-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050609-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050609-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050609-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050609-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Erythrocin Lactobionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERYTHROMYCIN LACTOBIONATE500 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33H58I7GLQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1668264Internal RxNorm lookup
1668267Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a96c405f-bd70-4bb4-719e-ac6a79dcc213Available on FDA.report

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
0409-6482-01Erythrocin Lactobionate10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,1025
0409-6482-11Erythrocin Lactobionate10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6482-01EA - Each0409-648254ffcc3e-335e-4cd4-b55f-10f60482526712012-07-24
0409-6482-11EA - Each0409-64822ef32e8d-8f0c-4fd3-b1ae-7777a3942f6912018-10-11

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-6482ERYTHROCIN LACTOBIONATE (ERYTHROMYCIN LACTOBIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]24Current NDC, Legacy NDC, 2 package rows20230930_a96c405f-bd70-4bb4-719e-ac6a79dcc213.zip

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Erythrocin LactobionateERYTHROMYCIN LACTOBIONATEHospira, Inc.a96c405f-bd70-4bb4-719e-ac6a79dcc2132025-10-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 050609
application number: NDA050609
ndc (product): 0409-6482

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1668267Erythrocin Lactobionate 500 MG InjectionPSNa96c405f-bd70-4bb4-719e-ac6a79dcc21325
1668264erythromycin lactobionate 500 MG InjectionPSNa96c405f-bd70-4bb4-719e-ac6a79dcc21325
1668267erythromycin lactobionate 500 MG Injection [Erythrocin]SBDa96c405f-bd70-4bb4-719e-ac6a79dcc21325
1668264erythromycin lactobionate 500 MG InjectionSCDa96c405f-bd70-4bb4-719e-ac6a79dcc21325
1668267Erythrocin 500 MG InjectionSYa96c405f-bd70-4bb4-719e-ac6a79dcc21325
1668267Erythrocin Lactobionate 500 MG InjectionSYa96c405f-bd70-4bb4-719e-ac6a79dcc21325

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-6482-010040964820110 VIAL in 1 TRAY (0409-6482-01) / 10 mL in 1 VIAL (0409-6482-11) 10 vial2005-05-250000-00-00NoNoCurrent
0409-6482-110040964821110 mL in 1 VIAL10 mlHistorical