ERY-TAB

Product NDC
55289-217
11-digit product format
552890217
Labeler code
55289
Product ID
55289-217_e6eb5cc4-cb16-39cd-e053-2995a90aa603
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA062298
Marketing category
ANDA
Marketing start
2011-04-18
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
55289-217-28EA - Each55289-2173458231b-46fc-4d0c-9eff-01973314225512013-02-13
55289-217-40EA - Each55289-217b3a751bf-f2da-4c05-9e21-255b143226ee12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ErythromycinACTIVE INGREDIENT63937KV33DERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
ErythromycinACTIVE MOIETY63937KV33DERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
AmmoniaINACTIVE INGREDIENT5138Q19F1XERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
crospovidoneINACTIVE INGREDIENT68401960MKERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
hypromellose phthalate (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
povidoneINACTIVE INGREDIENTFZ989GH94EERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
sorbitan monooleateINACTIVE INGREDIENT06XEA2VD56ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-217ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]17Legacy NDC20241011_3acbc324-9a11-4e48-b5ad-b4cc3b38dd48.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-217-285528902172828 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-217-28) 2011-12-210000-00-00NoNoCurrent
55289-217-405528902174040 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-217-40) 2011-12-210000-00-00NoNoCurrent