What is NDC 61919-401?

61919-401 is the product NDC for Amoxicillin, Amoxicillin 400 mg/5mL powder, for suspension, listed with the FDA by DIRECT RX. It has 1 package NDC, shown above in 10- and 11-digit form.

DIRECT RX, NDC labeler code 61919. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Amoxicillin?

274 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amoxicillin NDC 61919-401 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61919-401Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61919-0401Add 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
61919-401-32	6191904013261919040132	100 mL in 1 BOTTLE (61919-401-32)Marketed from Jun 19, 2020

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): Amoxicillin
Generic name (nonproprietary): amoxicillin
Active ingredients: Amoxicillin — 400 mg/5mL
Dosage form: Powder, For suspension
Route: Oral
Labeler: DIRECT RXNDC labeler code 61919
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065334
Marketing start: Jan 1, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)
Identifiers: Product ID 61919-401_0e877b33-af19-d857-e063-6394a90a08eaSPL ID 0e877b33-af19-d857-e063-6394a90a08eaSPL set ID 0173e9de-a995-4386-bb65-8fc2bbf347f9RxCUI 308189, 617296UNII 804826J2HU
Pharmacologic class: Penicillin-class Antibacterial

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

N461919040132 followed by a unit qualifier and the quantity

Package 61919-0401-32. 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 9, 2024.

Indications (excerpt from the label)

INDICATIONS & USAGE SECTION To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension, USP and other antibacterial drugs, amoxicillin for oral suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by 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. Amoxicillin for oral suspension, USP is indicated in the treatment of infections due to susceptible (ONLY β-lactam…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61919-401

What is NDC 61919-401?: 61919-401 is the product NDC for Amoxicillin, Amoxicillin 400 mg/5mL powder, for suspension, listed with the FDA by DIRECT RX. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amoxicillin.
What is the active ingredient?: Amoxicillin.
Who is the labeler?: DIRECT RX, NDC labeler code 61919. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amoxicillin?: 274 other product NDCs are listed under this name. See all Amoxicillin 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 Amoxicillin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Amoxicillin	Amoxicillin 250 mg/1	CapsuleOral	Northwind Health Company, LLC	82868-088	82868-0088-30
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0734	67046-0734-03
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4152	68788-4152-02
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	Coupler LLC	67046-0316	67046-0316-03
Amoxicillin	Amoxicillin 250 mg/1	CapsuleOral	Coupler LLC	67046-0127	67046-0127-03
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0015	67046-0015-03
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	Coupler LLC	67046-1175	67046-1175-03
Amoxicillin	Amoxicillin 875 mg/1	Tablet, CoatedOral	Preferred Pharmaceuticals Inc.	68788-4062	68788-4062-02
Amoxicillin	Amoxicillin 400 mg/5mL	For suspensionOral	REMEDYREPACK INC.	70518-4529	70518-4529-00
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	REMEDYREPACK INC.	70518-4522	70518-4522-00

All 275 Amoxicillin NDCs

Other NDCs under ANDA 065334

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

FDA NDC Directory listings under ANDA 065334
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-6323
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-6355
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-6680
Amoxicillin	Amoxicillin 200 mg/5mL	Powder, For suspensionOral	Rising Pharma Holdings, Inc.	57237-032
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	Rising Pharma Holdings, Inc.	57237-033
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	Proficient Rx LP	63187-262
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	Proficient Rx LP	63187-335
Amoxicillin	Amoxicillin 200 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	65862-070
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	65862-071
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	NuCare Pharmaceuticals,Inc.	68071-5109
Amoxicillin	Amoxicillin 200 mg/5mL	Powder, For suspensionOral	Preferred Pharmaceuticals Inc.	68788-8324
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	Preferred Pharmaceuticals Inc.	68788-8325
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	REMEDYREPACK INC.	70518-4522
Amoxicillin	Amoxicillin 200 mg/5mL	Powder, For suspensionOral	Proficient Rx LP	71205-775
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	DirectRx	72189-285