FDA.reportPublic FDA data

Erythromycin

Product NDC
55289-025
11-digit product format
552890025
Labeler code
55289
Product ID
55289-025_e6e99fde-0aed-67d8-e053-2a95a90a32b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA061621
Marketing category
ANDA
Marketing start
2011-09-06
Marketing end
0000-00-00
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
2023-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-025-04EA - Each55289-0250ec07be5-2cfa-4a15-9805-574e32e2afdc12013-02-13
55289-025-20EA - Each55289-02500f92413-7b54-4e10-88ac-dd88ddfb460f12013-02-13
55289-025-28EA - Each55289-0253c179513-0364-4ad4-8623-8bc513acb14512013-02-13
55289-025-30EA - Each55289-025916f7372-d44f-48ea-8678-7723b25b03b712013-02-13
55289-025-40EA - Each55289-0256be6ab10-85ac-4e1e-9ea6-de6650d0cacf12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
55289-025ERYTHROMYCIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]19Legacy NDC20241011_5d19702d-bb87-4f6b-84e5-35424611404a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-025-04552890025044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-025-04) 2012-05-040000-00-00NoNoCurrent
55289-025-205528900252020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-025-20) 2012-05-040000-00-00NoNoCurrent
55289-025-285528900252828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-025-28) 2012-05-040000-00-00NoNoCurrent
55289-025-305528900253030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-025-30) 2012-05-040000-00-00NoNoCurrent
55289-025-405528900254040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-025-40) 2012-05-040000-00-00NoNoCurrent