FDA.reportPublic FDA data

Erythromycin

Product NDC
71209-100
11-digit product format
712090100
Labeler code
71209
Product ID
71209-100_feeef834-a0cb-482c-b5bc-078be4f94e38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA213628
Marketing category
ANDA
Marketing start
2021-10-06
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
Rxcui197650, 598006

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
71209-100-01Erythromycin30 in 1 BOTTLETABLET, FILM COATED303
71209-100-05Erythromycin100 in 1 BOTTLETABLET, FILM COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-100ERYTHROMYCIN TABLET, FILM COATED [CADILA PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 2 package rows20231224_fae8fc38-3c60-43b8-a0f9-2c50df332505.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598006erythromycin 250 MG Oral TabletPSNfae8fc38-3c60-43b8-a0f9-2c50df3325053
197650erythromycin 500 MG Oral TabletPSNfae8fc38-3c60-43b8-a0f9-2c50df3325053
598006erythromycin 250 MG Oral TabletSCDfae8fc38-3c60-43b8-a0f9-2c50df3325053
197650erythromycin 500 MG Oral TabletSCDfae8fc38-3c60-43b8-a0f9-2c50df3325053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71209-100-017120901000130 TABLET, FILM COATED in 1 BOTTLE (71209-100-01) 2021-10-060000-00-00NoNoCurrent
71209-100-0571209010005100 TABLET, FILM COATED in 1 BOTTLE (71209-100-05) 2021-10-060000-00-00NoNoCurrent