FDA.reportPublic FDA data

Erythromycin

Product NDC
52536-180
11-digit product format
525360180
Labeler code
52536
Product ID
52536-180_292b4c82-0b72-5283-e063-6394a90ad2ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Wilshire Pharmaceuticals
Application
ANDA062298
Marketing category
ANDA
Marketing start
2019-07-22
Substance
ERYTHROMYCIN
Active strength
250 mg/1
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERYTHROMYCIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63937KV33D
Rxcui310155, 310157, 315090

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
52536-180-03Erythromycin30 in 1 BOTTLETABLET, DELAYED RELEASE302
52536-180-10Erythromycin100 in 1 BOTTLETABLET, DELAYED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52536-180-03EA - Each52536-1803a7fc532-645c-44ab-9676-1a5e6322485612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52536-180ERYTHROMYCIN TABLET, DELAYED RELEASE [WILSHIRE PHARMACEUTICALS]2Current NDC, Legacy NDC, 2 package rows20241215_e9b5abbb-2952-44ce-8cbb-415d9be23df4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310155erythromycin 250 MG Delayed Release Oral TabletPSNe9b5abbb-2952-44ce-8cbb-415d9be23df42
315090erythromycin 333 MG Delayed Release Oral TabletPSNe9b5abbb-2952-44ce-8cbb-415d9be23df42
310157erythromycin 500 MG Delayed Release Oral TabletPSNe9b5abbb-2952-44ce-8cbb-415d9be23df42
310155erythromycin 250 MG Delayed Release Oral TabletSCDe9b5abbb-2952-44ce-8cbb-415d9be23df42
315090erythromycin 333 MG Delayed Release Oral TabletSCDe9b5abbb-2952-44ce-8cbb-415d9be23df42
310157erythromycin 500 MG Delayed Release Oral TabletSCDe9b5abbb-2952-44ce-8cbb-415d9be23df42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52536-180-035253601800330 TABLET, DELAYED RELEASE in 1 BOTTLE (52536-180-03) 2019-07-220000-00-00NoNoCurrent
52536-180-1052536018010100 TABLET, DELAYED RELEASE in 1 BOTTLE (52536-180-10) 2019-07-220000-00-00NoNoCurrent