ERY-TAB

Product NDC
43063-569
11-digit product format
430630569
Labeler code
43063
Product ID
43063-569_e68a6acb-8181-4765-e053-2a95a90af0e9
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
333 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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ErythromycinACTIVE INGREDIENT63937KV33DERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
ErythromycinACTIVE MOIETY63937KV33DERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
AmmoniaINACTIVE INGREDIENT5138Q19F1XERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
crospovidoneINACTIVE INGREDIENT68401960MKERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
diacetylated monoglyceridesINACTIVE INGREDIENT5Z17386USFERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
hydroxypropyl cellulose (type H)INACTIVE INGREDIENTRFW2ET671PERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
hypromellose phthalate (24% phthalate, 55 CST)INACTIVE INGREDIENT87Y6436BKRERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
hypromellosesINACTIVE INGREDIENT3NXW29V3WOERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
magnesium stearateINACTIVE INGREDIENT70097M6I30ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
povidonesINACTIVE INGREDIENTFZ989GH94EERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
sorbitan monooleateINACTIVE INGREDIENT06XEA2VD56ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
talcINACTIVE INGREDIENT7SEV7J4R1UERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-569ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]16Legacy NDC20241013_5b783a3b-881d-4dd3-953c-97011c962dae.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-569-304306305693030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-569-30) 2015-04-140000-00-00NoNoCurrent