FDA.reportPublic FDA data

ERY-TAB

Product NDC
21695-457
11-digit product format
216950457
Labeler code
21695
Product ID
21695-457_e142a363-a8b8-40b9-ae9d-28777367e718
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
erythromycin
Dosage form
TABLET, DELAYED RELEASE
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
333 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
21695-457-152019-09-24C16284748780-1934fe258-4c9b-48b1-e053-8cdaa90a720aERY-TAB® (erythromycin delayed-release tablets, USP) ENTERIC-COATED
21695-457-212019-09-24C16284748780-1934fe258-4c9b-48b1-e053-8cdaa90a720aERY-TAB® (erythromycin delayed-release tablets, USP) ENTERIC-COATED
21695-457-302019-09-24C16284748780-1934fe258-4c9b-48b1-e053-8cdaa90a720aERY-TAB® (erythromycin delayed-release tablets, USP) ENTERIC-COATED

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-457-15ERY-TAB15 in 1 BOTTLETABLET, DELAYED RELEASE151
21695-457-21ERY-TAB21 in 1 BOTTLETABLET, DELAYED RELEASE211
21695-457-30ERY-TAB30 in 1 BOTTLETABLET, DELAYED RELEASE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
erythromycinACTIVE INGREDIENT63937KV33DERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
erythromycinACTIVE MOIETY63937KV33DERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1UERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-457ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20101126_e142a363-a8b8-40b9-ae9d-28777367e718.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
206078ERY-TAB 333 MG Delayed Release Oral TabletPSNe142a363-a8b8-40b9-ae9d-28777367e7181
315090erythromycin 333 MG Delayed Release Oral TabletPSNe142a363-a8b8-40b9-ae9d-28777367e7181
206078erythromycin 333 MG Delayed Release Oral Tablet [Ery-Tab]SBDe142a363-a8b8-40b9-ae9d-28777367e7181
315090erythromycin 333 MG Delayed Release Oral TabletSCDe142a363-a8b8-40b9-ae9d-28777367e7181
206078Ery-Tab 333 MG Delayed Release Oral TabletSYe142a363-a8b8-40b9-ae9d-28777367e7181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-457-152169504571515 in 1 BOTTLEHistorical
21695-457-212169504572121 in 1 BOTTLEHistorical
21695-457-302169504573030 in 1 BOTTLEHistorical