FDA.reportPublic FDA data

Erythromycin

Product NDC
69238-1473
11-digit product format
692381473
Labeler code
69238
Product ID
69238-1473_ecd62575-1fd6-4ed0-ba18-048be51a607c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA210954
Marketing category
ANDA
Marketing start
2019-07-07
Substance
ERYTHROMYCIN
Active strength
500 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
ERYTHROMYCIN500 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
69238-1473-1Erythromycin100 in 1 BOTTLETABLET, DELAYED RELEASE10010
69238-1473-3Erythromycin30 in 1 BOTTLETABLET, DELAYED RELEASE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1473-1EA - Each69238-147319893e3c-89f1-4b46-986a-e59d1e095dce12019-08-06
69238-1473-3EA - Each69238-1473b623a977-6c59-4368-aacb-b2e4b817c6fa12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1473ERYTHROMYCIN TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]10Current NDC, Legacy NDC, 2 package rows20241219_bb641ed4-8093-4e15-9cb9-8921b1093d50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310155erythromycin 250 MG Delayed Release Oral TabletPSNbb641ed4-8093-4e15-9cb9-8921b1093d5010
315090erythromycin 333 MG Delayed Release Oral TabletPSNbb641ed4-8093-4e15-9cb9-8921b1093d5010
310157erythromycin 500 MG Delayed Release Oral TabletPSNbb641ed4-8093-4e15-9cb9-8921b1093d5010
310155erythromycin 250 MG Delayed Release Oral TabletSCDbb641ed4-8093-4e15-9cb9-8921b1093d5010
315090erythromycin 333 MG Delayed Release Oral TabletSCDbb641ed4-8093-4e15-9cb9-8921b1093d5010
310157erythromycin 500 MG Delayed Release Oral TabletSCDbb641ed4-8093-4e15-9cb9-8921b1093d5010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1473-169238147301100 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1473-1) 2019-07-070000-00-00NoNoCurrent
69238-1473-36923814730330 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1473-3) 2021-08-270000-00-00NoNoCurrent