What is NDC 63629-8251?

63629-8251 is the product NDC for Azithromycin, Azithromycin dihydrate 500 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 63629. 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 63629-8251 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8251Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8251Add 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
63629-8251-1	6362982510163629825101	30 TABLET, FILM COATED in 1 BOTTLE (63629-8251-1)Marketed from Dec 18, 2019
63629-8251-2	6362982510263629825102	5 TABLET, FILM COATED in 1 BOTTLE (63629-8251-2)Marketed from Nov 5, 2019
63629-8251-3	6362982510363629825103	2 TABLET, FILM COATED in 1 BOTTLE (63629-8251-3)Marketed from Nov 5, 2019
63629-8251-4	6362982510463629825104	6 TABLET, FILM COATED in 1 BOTTLE (63629-8251-4)Marketed from Nov 5, 2019
63629-8251-5	6362982510563629825105	4 TABLET, FILM COATED in 1 BOTTLE (63629-8251-5)Marketed from Nov 5, 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): Azithromycin
Generic name (nonproprietary): azithromycin
Active ingredients: Azithromycin dihydrate — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207398
Marketing start: Jul 5, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 63629-8251_cccc52bf-178d-42ba-9731-76dd4681f19bSPL ID cccc52bf-178d-42ba-9731-76dd4681f19bSPL set ID a81212ef-76b6-4bd7-8706-3d2b05ee34f9RxCUI 248656UNII 5FD1131I7S
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

N463629825101 followed by a unit qualifier and the quantity

Package 63629-8251-01. 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 Mar 30, 2026.

Indications (excerpt from the label)

Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2) ] Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1 ) Acute bacterial sinusitis in adults ( 1.1 ) Uncomplicated skin and skin structure infections in adults ( 1.1 ) Urethritis…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-8251

What is NDC 63629-8251?: 63629-8251 is the product NDC for Azithromycin, Azithromycin dihydrate 500 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Azithromycin.
What is the active ingredient?: Azithromycin dihydrate.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 63629. 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 207398

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

FDA NDC Directory listings under ANDA 207398
Product	Strength	Form · route	Labeler	Product NDC
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5366
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5376
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-8013
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-8017
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-642
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-1945
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4976
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-5058
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-5082
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7598
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3508
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-519
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2669
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-015