FDA.reportPublic FDA data

ERYTHROMYCIN Base Filmtab

Product NDC
21695-389
11-digit product format
216950389
Labeler code
21695
Product ID
21695-389_e83ebf1a-2719-4f52-a47d-3d5af9e8d6f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ERYTHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA061621
Marketing category
ANDA
Marketing start
1972-07-11
Marketing end
0000-00-00
Substance
ERYTHROMYCIN
Active strength
500 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-389-302019-09-24C16284748780-1934fe258-4cbc-48b1-e053-8cdaa90a720aERYTHROMYCIN Base Filmtab® (erythromycin tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-389-30ERYTHROMYCIN Base Filmtab30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-389-30EA - Each21695-3892e238f5d-809b-427a-8b20-027b96d4a21712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ERYTHROMYCINACTIVE INGREDIENT63937KV33DERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ERYTHROMYCINACTIVE MOIETY63937KV33DERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
sorbic acidINACTIVE INGREDIENTX045WJ989BERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1UERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-389ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110103_e83ebf1a-2719-4f52-a47d-3d5af9e8d6f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598006erythromycin 250 MG Oral TabletPSNe83ebf1a-2719-4f52-a47d-3d5af9e8d6f41
197650erythromycin 500 MG Oral TabletPSNe83ebf1a-2719-4f52-a47d-3d5af9e8d6f41
598006erythromycin 250 MG Oral TabletSCDe83ebf1a-2719-4f52-a47d-3d5af9e8d6f41
197650erythromycin 500 MG Oral TabletSCDe83ebf1a-2719-4f52-a47d-3d5af9e8d6f41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-389-302169503893030 in 1 BOTTLEHistorical