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Erythrocin Stearate

ERYTHROCIN STEARATE ERYTHROMYCIN STEARATE TABLETS, USP

Approved
Approval ID

26f2704c-92ae-41c5-badc-dbebfb2eed35

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 22, 2023

Manufacturers
FDA

PD-Rx Pharmaceuticals, Inc.

DUNS: 156893695

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ERYTHROMYCIN STEARATE

PRODUCT DETAILS

NDC Product Code55289-112
Application NumberANDA060359
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 22, 2023
Generic NameERYTHROMYCIN STEARATE

INGREDIENTS (13)

POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
ERYTHROMYCIN STEARATEActive
Quantity: 250 mg in 1 1
Code: LXW024X05M
Classification: ACTIM
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 12/4/2018

HOW SUPPLIED

ERYTHROCIN ® STEARATE Film-coated Tablets (erythromycin stearate tablets, USP) are supplied in the following strengths and packages.

ERYTHROCIN ® STEARATE Film-coated, 250 mg pink tablets imprinted with the Product Code designation ES:

Bottles of 4 NDC 55289-112-04

Bottles of 10 NDC 55289-112-10

Bottles of 15 NDC 55289-112-15

Bottles of 20 NDC 55289-112-20

Bottles of 28 NDC 55289-112-28

Bottles of 40 NDC 55289-112-40

Bottles of 56 NDC 55289-112-56

Bottles of 100 NDC 55289-112-01

Bottles of 120 NDC 55289-112-98

Recommended Storage

Store below 86°F (30°C).

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Erythrocin Stearate - FDA Drug Approval Details