What is NDC 68094-690?

68094-690 is the product NDC for Azithromycin Dihydrate, Azithromycin dihydrate 600 mg/1 tablet, film coated, listed with the FDA by Precision Dose, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Precision Dose, Inc., NDC labeler code 68094. 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 Dihydrate?

42 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Azithromycin Dihydrate NDC 68094-690

NDC codes

FDA NDC Directory

Product NDC (as listed)68094-690Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68094-0690Add 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
68094-690-30	6809406903068094069030	30 TABLET, FILM COATED in 1 BOTTLE (68094-690-30)Marketed from Feb 15, 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): Azithromycin Dihydrate
Generic name (nonproprietary): azithromycin dihydrate
Active ingredients: Azithromycin dihydrate — 600 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Precision Dose, Inc.NDC labeler code 68094
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207566
Marketing start: Feb 15, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 68094-690_5d373887-5ca3-4911-bd76-0ff51141df5fSPL ID 5d373887-5ca3-4911-bd76-0ff51141df5fSPL set ID b88f5839-8e8b-4bf6-a577-5c8b7cffeec6RxCUI 204844UNII 5FD1131I7SUPC 0368094690300
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

N468094069030 followed by a unit qualifier and the quantity

Package 68094-0690-30. 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 Nov 30, 2023.

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. Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Mycobacterial Infections ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.3 ) 1.2 Mycobacterial Infections Pr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68094-690

What is NDC 68094-690?: 68094-690 is the product NDC for Azithromycin Dihydrate, Azithromycin dihydrate 600 mg/1 tablet, film coated, listed with the FDA by Precision Dose, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Azithromycin Dihydrate.
What is the active ingredient?: Azithromycin dihydrate.
Who is the labeler?: Precision Dose, Inc., NDC labeler code 68094. 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 Dihydrate?: 42 other product NDCs are listed under this name. See all Azithromycin Dihydrate 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 Dihydrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1607	67046-1607-03
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1502	67046-1502-03
azithromycin dihydrate	Azithromycin dihydrate 600 mg/1	TabletOral	Coupler LLC	67046-1503	67046-1503-03
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8800	68788-8800-06
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8773	68788-8773-0368788-8773-04
Azithromycin Dihydrate	Azithromycin dihydrate 600 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4202	70518-4202-00
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Quality Care Products, LLC	83008-081	83008-0081-06
azithromycin dihydrate	Azithromycin dihydrate 250 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0431	80425-0431-01
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4160	70518-4160-0070518-4160-0170518-4160-02+3 more
azithromycin dihydrate	Azithromycin dihydrate 500 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0412	80425-0412-01

All 43 Azithromycin Dihydrate NDCs

Other NDCs under ANDA 207566

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

FDA NDC Directory listings under ANDA 207566
Product	Strength	Form · route	Labeler	Product NDC
Azithromycin Dihydrate	Azithromycin dihydrate 600 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4202