What is NDC 75834-294?

75834-294 is the product NDC for Erythromycin Ethylsuccinate, Erythromycin ethylsuccinate 400 mg/5mL suspension, listed with the FDA by Nivagen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Nivagen Pharmaceuticals, Inc., NDC labeler code 75834. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Erythromycin Ethylsuccinate NDC 75834-294

NDC codes

FDA NDC Directory

Product NDC (as listed)75834-294Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75834-0294Add 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 NDC	11-digit (billing)	Package	Copy
75834-294-01	7583402940175834029401	100 mL in 1 BOTTLE (75834-294-01)Marketed from Feb 1, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 ethylsuccinate
Active ingredients: Erythromycin ethylsuccinate — 400 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: Nivagen Pharmaceuticals, Inc.NDC labeler code 75834
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216212
Marketing start: Feb 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
Identifiers: Product ID 75834-294_7f06e8f4-15fb-4e18-b57e-457e7e20d331SPL ID 7f06e8f4-15fb-4e18-b57e-457e7e20d331SPL set ID 46f74c4f-10fc-44cf-aec4-d113f49149bcRxCUI 686400, 686418UNII 1014KSJ86FUPC 0375834295015, 0375834294018
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

N475834029401 followed by a unit qualifier and the quantity

Package 75834-0294-01. 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 Jan 2, 2024.

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 75834-294

What is NDC 75834-294?: 75834-294 is the product NDC for Erythromycin Ethylsuccinate, Erythromycin ethylsuccinate 400 mg/5mL suspension, listed with the FDA by Nivagen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Erythromycin Ethylsuccinate.
What is the active ingredient?: Erythromycin ethylsuccinate.
Who is the labeler?: Nivagen Pharmaceuticals, Inc., NDC labeler code 75834. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Erythromycin Ethylsuccinateerythromycin	Erythromycin ethylsuccinate 200 mg/5mL	SuspensionOral	Amneal Pharmaceuticals NY LLC	60219-1503	60219-1503-01
Erythromycin Ethylsuccinateerythromycin	Erythromycin ethylsuccinate 400 mg/5mL	SuspensionOral	Amneal Pharmaceuticals NY LLC	60219-1504	60219-1504-02
Erythromycin Ethylsuccinate	Erythromycin ethylsuccinate 200 mg/5mL	SuspensionOral	Nivagen Pharmaceuticals, Inc.	75834-295	75834-0295-01
Erythromycin ethylsuccinate	Erythromycin ethylsuccinate 200 mg/5mL	For suspensionOral	Cadila Pharmaceuticals Limited	71209-102	71209-0102-21
Erythromycin ethylsuccinate	Erythromycin ethylsuccinate 400 mg/5mL	For suspensionOral	Cadila Pharmaceuticals Limited	71209-103	71209-0103-21
Erythromycin ethylsuccinate	Erythromycin ethylsuccinate 200 mg/5mL	For suspensionOral	Bryant Ranch Prepack	72162-2657	72162-2657-01
Erythromycin ethylsuccinate	Erythromycin ethylsuccinate 400 mg/5mL	For suspensionOral	Bryant Ranch Prepack	72162-2658	72162-2658-01
Erythromycin ethylsuccinate	Erythromycin ethylsuccinate 200 mg/5mL	For suspensionOral	Kanchan Healthcare Inc	85742-029	85742-0029-28
Erythromycin ethylsuccinate	Erythromycin ethylsuccinate 400 mg/5mL	For suspensionOral	Kanchan Healthcare Inc	85742-030	85742-0030-28
Erythromycin Ethylsuccinate	Erythromycin ethylsuccinate 200 mg/5mL	SuspensionOral	Wilshire Pharmaceuticals	52536-132	52536-0132-13

All 20 Erythromycin Ethylsuccinate NDCs

Other NDCs under ANDA 216212

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

FDA NDC Directory listings under ANDA 216212
Product	Strength	Form · route	Labeler	Product NDC
Erythromycin ethylsuccinate	Erythromycin ethylsuccinate 200 mg/5mL	For suspensionOral	Cadila Pharmaceuticals Limited	71209-102
Erythromycin ethylsuccinate	Erythromycin ethylsuccinate 400 mg/5mL	For suspensionOral	Cadila Pharmaceuticals Limited	71209-103
Erythromycin ethylsuccinate	Erythromycin ethylsuccinate 200 mg/5mL	For suspensionOral	Bryant Ranch Prepack	72162-2657
Erythromycin ethylsuccinate	Erythromycin ethylsuccinate 400 mg/5mL	For suspensionOral	Bryant Ranch Prepack	72162-2658
Erythromycin Ethylsuccinate	Erythromycin ethylsuccinate 200 mg/5mL	SuspensionOral	Nivagen Pharmaceuticals, Inc.	75834-295
Erythromycin ethylsuccinate	Erythromycin ethylsuccinate 200 mg/5mL	For suspensionOral	Kanchan Healthcare Inc	85742-029
Erythromycin ethylsuccinate	Erythromycin ethylsuccinate 400 mg/5mL	For suspensionOral	Kanchan Healthcare Inc	85742-030