FDA.reportPublic FDA data

Erythromycin

Product NDC
0093-5572
11-digit product format
000935572
Labeler code
0093
Product ID
0093-5572_f750327c-00a6-48d0-9a87-b5b0af53a3c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA214549
Marketing category
ANDA
Marketing start
2021-05-04
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
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
0093-5572-01Erythromycin100 in 1 BOTTLETABLET, FILM COATED1003
0093-5572-56Erythromycin30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5572-01EA - Each0093-557238e00abe-e4e3-49f2-b395-639052a1d81f12021-06-02
0093-5572-56EA - Each0093-5572bcd90f22-2062-4cef-82cd-bd6e6b9becfa12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5572ERYTHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]3Current NDC, Legacy NDC, 2 package rows20250418_75a0bd5a-d09f-483b-bfd8-f8343b149eb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598006erythromycin 250 MG Oral TabletPSN75a0bd5a-d09f-483b-bfd8-f8343b149eb23
197650erythromycin 500 MG Oral TabletPSN75a0bd5a-d09f-483b-bfd8-f8343b149eb23
598006erythromycin 250 MG Oral TabletSCD75a0bd5a-d09f-483b-bfd8-f8343b149eb23
197650erythromycin 500 MG Oral TabletSCD75a0bd5a-d09f-483b-bfd8-f8343b149eb23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-5572-0100093557201100 TABLET, FILM COATED in 1 BOTTLE (0093-5572-01) 2021-05-040000-00-00NoNoCurrent
0093-5572-560009355725630 TABLET, FILM COATED in 1 BOTTLE (0093-5572-56) 2021-05-040000-00-00NoNoCurrent
0093-5572-99000935572998565 TABLET, FILM COATED in 1 CONTAINER (0093-5572-99)12-FEB-21Current