Erythromycin
ERYTHROMYCIN TABLETS, USP
Approved
Approval ID
f2efbc94-64f7-4130-ab23-e5983854f730
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2019
Manufacturers
FDA
Wilshire Pharmaceuticals
DUNS: 078657245
Products 2
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 Code52536-103
Application NumberANDA061621
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2019
FDA Product Classification
INGREDIENTS (19)
ErythromycinActive
Quantity: 250 mg in 1 1
Code: 63937KV33D
Classification: ACTIB
D&C Red No. 30Inactive
Code: 2S42T2808B
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
crospovidone (15 MPA.S at 5%)Inactive
Code: 68401960MK
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
sorbic acidInactive
Code: X045WJ989B
Classification: IACT
sorbitan monooleateInactive
Code: 06XEA2VD56
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULR
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Erythromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52536-105
Application NumberANDA061621
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2019
FDA Product Classification
INGREDIENTS (20)
ErythromycinActive
Quantity: 500 mg in 1 1
Code: 63937KV33D
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
crospovidone, unspecifiedInactive
Code: 2S7830E561
Classification: IACT
D&C Red No. 30Inactive
Code: 2S42T2808B
Classification: IACT
hydroxypropyl cellulose, unspecifiedInactive
Code: 9XZ8H6N6OH
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULR
Classification: IACT
sorbitan monooleateInactive
Code: 06XEA2VD56
Classification: IACT
sorbic acidInactive
Code: X045WJ989B
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 1/14/2019
EBAG-PI-02
Revised: January 2019
Wilshire Pharmaceuticals, Inc.
Atlanta, GA 30328
(Nos. 6326 and 6227)