ERYTHROMYCIN
ERYTHROMYCIN DELAYED-RELEASE CAPSULES, USP
Approved
Approval ID
ddd9ad9a-fc60-409a-a2b3-be51482ef751
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 19, 2019
Manufacturers
FDA
Arbor Pharmaceuticals, Inc.
DUNS: 781796417
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Erythromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-120
Application NumberANDA062746
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 19, 2019
FDA Product Classification
INGREDIENTS (11)
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
ErythromycinActive
Quantity: 250 mg in 1 1
Code: 63937KV33D
Classification: ACTIB
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
powdered celluloseInactive
Code: SMD1X3XO9M
Classification: IACT
D&C Red No. 30Inactive
Code: 2S42T2808B
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
gelatin, unspecifiedInactive
Code: 2G86QN327L
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C Red No. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT