FDA.reportPublic FDA data

ERYTHROMYCIN

Product NDC
75834-243
11-digit product format
758340243
Labeler code
75834
Product ID
75834-243_e40dea9d-181d-4775-8912-ac1fc0d84b23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ERYTHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA213628
Marketing category
ANDA
Marketing start
2021-07-15
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
75834-243-01ERYTHROMYCIN100 in 1 BOTTLETABLET, FILM COATED1002
75834-243-30ERYTHROMYCIN30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-243-01EA - Each75834-2433170bb9a-526e-4eea-a8d4-18a6c2c6f9c912021-09-07
75834-243-30EA - Each75834-2434956f285-7f0f-4a69-a257-56dbc83dfa7312021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-243ERYTHROMYCIN TABLET, FILM COATED [NIVAGEN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20240117_aa61cb37-5fc5-4225-b894-1d660386777f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598006erythromycin 250 MG Oral TabletPSNaa61cb37-5fc5-4225-b894-1d660386777f2
197650erythromycin 500 MG Oral TabletPSNaa61cb37-5fc5-4225-b894-1d660386777f2
598006erythromycin 250 MG Oral TabletSCDaa61cb37-5fc5-4225-b894-1d660386777f2
197650erythromycin 500 MG Oral TabletSCDaa61cb37-5fc5-4225-b894-1d660386777f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
75834-243-0175834024301100 TABLET, FILM COATED in 1 BOTTLE (75834-243-01) 2021-07-150000-00-00NoNoCurrent
75834-243-307583402433030 TABLET, FILM COATED in 1 BOTTLE (75834-243-30) 2021-07-150000-00-00NoNoCurrent