FDA.reportPublic FDA data

Erythromycin

Product NDC
24338-104
11-digit product format
243380104
Labeler code
24338
Product ID
24338-104_1afb465a-744a-48a9-a74b-9dad81fee83c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Arbor Pharmaceuticals, Inc.
Application
ANDA061621
Marketing category
ANDA
Marketing start
2011-09-06
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
24338-104-03Erythromycin30 in 1 BOTTLETABLET, FILM COATED3013
24338-104-13Erythromycin100 in 1 BOTTLETABLET, FILM COATED10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-104-03EA - Each24338-10410e2a586-a90b-47a1-9a32-eb650551fc1812017-12-14
24338-104-13EA - Each24338-104c77b3c99-6125-45fb-9edc-f2298d6e352512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ErythromycinACTIVE INGREDIENT63937KV33DERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
ErythromycinACTIVE MOIETY63937KV33DERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
aluminum oxideINACTIVE INGREDIENTLMI26O6933ERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
crospovidoneINACTIVE INGREDIENT68401960MKERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
D&C Red No. 30INACTIVE INGREDIENT2S42T2808BERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
hydroxypropyl cellulose (type H)INACTIVE INGREDIENTRFW2ET671PERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
hypromellose phthalate (24% phthalate, 55 CST)INACTIVE INGREDIENT87Y6436BKRERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
hypromellosesINACTIVE INGREDIENT3NXW29V3WOERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
magnesium stearateINACTIVE INGREDIENT70097M6I30ERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
povidonesINACTIVE INGREDIENTFZ989GH94EERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4ERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
sodium hydroxideINACTIVE INGREDIENT55X04QC32IERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
sorbic acidINACTIVE INGREDIENTX045WJ989BERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
sorbitan monooleateINACTIVE INGREDIENT06XEA2VD56ERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
talcINACTIVE INGREDIENT7SEV7J4R1UERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]9
ErythromycinACTIVE INGREDIENT63937KV33DERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
ErythromycinACTIVE MOIETY63937KV33DERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933ERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
crospovidoneINACTIVE INGREDIENT68401960MKERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
D&C Red No. 30INACTIVE INGREDIENT2S42T2808BERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30ERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
povidoneINACTIVE INGREDIENTFZ989GH94EERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4ERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
sorbic acidINACTIVE INGREDIENTX045WJ989BERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
sorbitan monooleateINACTIVE INGREDIENT06XEA2VD56ERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24338-104ERYTHROMYCIN TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 2 package rows20181208_ca1326d6-c5c6-4572-96b6-e56cd944799c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598006erythromycin 250 MG Oral TabletPSN661ad77d-8f9f-4366-a3de-2dc3acb1850d22
197650erythromycin 500 MG Oral TabletPSN661ad77d-8f9f-4366-a3de-2dc3acb1850d22
598006erythromycin 250 MG Oral TabletSCD661ad77d-8f9f-4366-a3de-2dc3acb1850d22
197650erythromycin 500 MG Oral TabletSCD661ad77d-8f9f-4366-a3de-2dc3acb1850d22
598006erythromycin 250 MG Oral TabletPSNca1326d6-c5c6-4572-96b6-e56cd944799c13
197650erythromycin 500 MG Oral TabletPSNca1326d6-c5c6-4572-96b6-e56cd944799c13
598006erythromycin 250 MG Oral TabletSCDca1326d6-c5c6-4572-96b6-e56cd944799c13
197650erythromycin 500 MG Oral TabletSCDca1326d6-c5c6-4572-96b6-e56cd944799c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24338-104-032433801040330 TABLET, FILM COATED in 1 BOTTLE (24338-104-03) 2017-11-200000-00-00NoNoCurrent
24338-104-1324338010413100 TABLET, FILM COATED in 1 BOTTLE (24338-104-13) 2011-09-060000-00-00NoNoCurrent