Prescription drug · ANDA

Erythromycin Ethylsuccinate (Erythromycin) NDC 69238-1504

Erythromycin ethylsuccinate 400 mg/5mL · Suspension · Oral · Amneal Pharmaceuticals NY LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)69238-1504Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69238-1504Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
69238-1504-269238150402100 mL in 1 BOTTLE (69238-1504-2)Marketed from Nov 4, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Erythromycin Ethylsuccinate
Generic name (nonproprietary)
erythromycin
Active ingredients
Erythromycin ethylsuccinate — 400 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211204
Marketing start
Listing expires
Other FDA classes
Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
Identifiers
Product ID 69238-1504_85c41da0-5783-4194-8bb5-7b14ad975d25SPL ID 85c41da0-5783-4194-8bb5-7b14ad975d25SPL set ID 596fa019-b0eb-4e57-93ff-195a765a2e91RxCUI 686400, 686418UNII 1014KSJ86FUPC 0369238150315, 0369238150421
Pharmacologic class
Macrolide Antimicrobial; Macrolide

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469238150402 followed by a unit qualifier and the quantity

Package 69238-1504-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin ethylsuccinate for oral suspension is indicated in the treatme…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69238-1504

What is NDC 69238-1504?
69238-1504 is the product NDC for Erythromycin Ethylsuccinate (erythromycin), Erythromycin ethylsuccinate 400 mg/5mL suspension, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Erythromycin Ethylsuccinate (Erythromycin).
What is the active ingredient?
Erythromycin ethylsuccinate.
Who is the labeler?
Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Erythromycin Ethylsuccinate?
19 other product NDCs are listed under this name. See all Erythromycin Ethylsuccinate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Erythromycin Ethylsuccinate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Erythromycin EthylsuccinateerythromycinErythromycin ethylsuccinate 200 mg/5mLSuspensionOralAmneal Pharmaceuticals NY LLC60219-150360219-1503-01
Erythromycin EthylsuccinateerythromycinErythromycin ethylsuccinate 400 mg/5mLSuspensionOralAmneal Pharmaceuticals NY LLC60219-150460219-1504-02
Erythromycin EthylsuccinateErythromycin ethylsuccinate 200 mg/5mLSuspensionOralNivagen Pharmaceuticals, Inc.75834-29575834-0295-01
Erythromycin EthylsuccinateErythromycin ethylsuccinate 400 mg/5mLSuspensionOralNivagen Pharmaceuticals, Inc.75834-29475834-0294-01
Erythromycin ethylsuccinateErythromycin ethylsuccinate 200 mg/5mLFor suspensionOralKanchan Healthcare Inc85742-02985742-0029-28
Erythromycin ethylsuccinateErythromycin ethylsuccinate 400 mg/5mLFor suspensionOralKanchan Healthcare Inc85742-03085742-0030-28
Erythromycin ethylsuccinateErythromycin ethylsuccinate 200 mg/5mLFor suspensionOralBryant Ranch Prepack72162-265772162-2657-01
Erythromycin ethylsuccinateErythromycin ethylsuccinate 400 mg/5mLFor suspensionOralBryant Ranch Prepack72162-265872162-2658-01
Erythromycin ethylsuccinateErythromycin ethylsuccinate 200 mg/5mLFor suspensionOralCadila Pharmaceuticals Limited71209-10271209-0102-21
Erythromycin ethylsuccinateErythromycin ethylsuccinate 400 mg/5mLFor suspensionOralCadila Pharmaceuticals Limited71209-10371209-0103-21

All 20 Erythromycin Ethylsuccinate NDCs

Other NDCs under ANDA 211204

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211204
ProductStrengthForm · routeLabelerProduct NDC
Erythromycin EthylsuccinateerythromycinErythromycin ethylsuccinate 200 mg/5mLSuspensionOralAmneal Pharmaceuticals NY LLC69238-1503
Erythromycin EthylsuccinateerythromycinErythromycin ethylsuccinate 200 mg/5mLSuspensionOralAmneal Pharmaceuticals NY LLC60219-1503
Erythromycin EthylsuccinateerythromycinErythromycin ethylsuccinate 400 mg/5mLSuspensionOralAmneal Pharmaceuticals NY LLC60219-1504

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Erythromycin Ethylsuccinate NDC 69238-1504 | Med-Code