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…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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