What is NDC 63187-189?

63187-189 is the product NDC for Azithromycin, Azithromycin monohydrate 500 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 2 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Azithromycin?

146 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Azithromycin NDC 63187-189 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-189Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0189Add 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
63187-189-03	6318701890363187018903	1 BLISTER PACK in 1 BOX (63187-189-03) / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 1, 2014
63187-189-04	6318701890463187018904	4 TABLET, FILM COATED in 1 BOTTLE (63187-189-04)Marketed from Sep 14, 2022

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): Azithromycin
Generic name (nonproprietary): azithromycin
Active ingredients: Azithromycin monohydrate — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065223
Marketing start: Jan 6, 2006
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 63187-189_d6250595-3500-4c6f-8175-25a8a92e2d5eSPL ID d6250595-3500-4c6f-8175-25a8a92e2d5eSPL set ID 7e7c2f49-449c-4ba2-98ae-0ff0c040614cRxCUI 248656, 308460, 749783UNII JTE4MNN1MDUPC 0363187189037, 0363187007041
Pharmacologic class: Macrolide Antimicrobial

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

N463187018903 followed by a unit qualifier and the quantity

Package 63187-0189-03. 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 Oct 1, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Azithromycin tablets USP are indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations. Adults Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumon…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-189

What is NDC 63187-189?: 63187-189 is the product NDC for Azithromycin, Azithromycin monohydrate 500 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Azithromycin.
What is the active ingredient?: Azithromycin monohydrate.
Who is the labeler?: Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Azithromycin?: 146 other product NDCs are listed under this name. See all Azithromycin 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 Azithromycin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1698	67046-1698-03
azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-726	64980-0726-0364980-0726-13
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-727	64980-0727-0364980-0727-16
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0508	67046-0508-03
Azithromycin	Azithromycin dihydrate 200 mg/5mL	Powder, For suspensionOral	AiPing Pharmaceutical, Inc.	11788-129	11788-0129-1311788-0129-1411788-0129-15
Azithromycin	Azithromycin dihydrate 100 mg/5mL	Powder, For suspensionOral	AiPing Pharmaceutical, Inc.	11788-128	11788-0128-13
Azithromycin	Azithromycin dihydrate 200 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-8144	50090-8144-00
Azithromycinazithromycin monohydrate	Azithromycin monohydrate 500 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-180	25021-0180-10
azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4367	70518-4367-0070518-4367-0170518-4367-03+1 more
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4356	70518-4356-00

All 147 Azithromycin NDCs

Other NDCs under ANDA 065223

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

FDA NDC Directory listings under ANDA 065223
Product	Strength	Form · route	Labeler	Product NDC
Azithromycin	Azithromycin monohydrate 500 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	50111-788
Azithromycin	Azithromycin monohydrate 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0599
Azithromycin	Azithromycin monohydrate 500 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-589
Azithromycin	Azithromycin monohydrate 500 mg/1	Tablet, Film coatedOral	Sportpharm LLC	85766-077