What is NDC 76420-838?

76420-838 is the product NDC for Amoxicillin, Amoxicillin 500 mg/1 tablet, film coated, listed with the FDA by Asclemed USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. 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?

268 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 76420-838 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-838Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0838Add 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
76420-838-01	76420083801	100 TABLET, FILM COATED in 1 BOTTLE (76420-838-01)Marketed from Aug 21, 2024
76420-838-20	76420083820	20 TABLET, FILM COATED in 1 BOTTLE (76420-838-20)Marketed from Aug 21, 2024

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 — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065256
Marketing start: Nov 9, 2005
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)
Identifiers: Product ID 76420-838_203ead37-92bb-9348-e063-6294a90ab111SPL ID 203ead37-92bb-9348-e063-6294a90ab111SPL set ID a18751fa-6202-4ae2-950a-a3f1dc9a8afdRxCUI 308192, 308194UNII 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

N476420083801 followed by a unit qualifier and the quantity

Package 76420-0838-01. 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 Aug 21, 2024.

Indications (excerpt from the label)

Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . Infections of the Genitourinary Tract: Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . Infections of the Skin and Skin Structure: Amoxicillin tablets are indicated in the treatment of infections due to sus…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-838

What is NDC 76420-838?: 76420-838 is the product NDC for Amoxicillin, Amoxicillin 500 mg/1 tablet, film coated, listed with the FDA by Asclemed USA, Inc.. It has 2 package NDCs, 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?: Asclemed USA, Inc., NDC labeler code 76420. 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?: 268 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 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
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	REMEDYREPACK INC.	70518-4521	70518-4521-00

All 269 Amoxicillin NDCs

Other NDCs under ANDA 065256

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

FDA NDC Directory listings under ANDA 065256
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	QPharma, Inc.	42708-078
Amoxicillin	Amoxicillin 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-0709
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-0713
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-0714
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1595
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1596
Amoxicillin	Amoxicillin 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1825
Amoxicillin	Amoxicillin 500 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-028
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-029
Amoxicillin	Amoxicillin 500 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-798
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-809
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-325
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-729
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-4777
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-015
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0015
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0734
Amoxicillin	Amoxicillin 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-2911
Amoxicillin	Amoxicillin 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3675
Amoxicillin	Amoxicillin 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3872

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