What is NDC 70095-025?

70095-025 is the product NDC for Azithromycin monohydrate, Azithromycin monohydrate 500 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 70095. 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 monohydrate?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Azithromycin monohydrate NDC 70095-025

NDC codes

FDA NDC Directory

Product NDC (as listed)70095-025Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70095-0025Add 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
70095-025-02	7009500250270095002502	10 VIAL in 1 CARTON (70095-025-02) / 10 mL in 1 VIAL (70095-025-01)Marketed from Mar 27, 2023

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 monohydrate
Generic name (nonproprietary): azithromycin monohydrate
Active ingredients: Azithromycin monohydrate — 500 mg/10mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 70095
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065501
Marketing start: Mar 27, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 70095-025_5b93f64d-eae3-ef5a-e063-6394a90a6583SPL ID 5b93f64d-eae3-ef5a-e063-6394a90a6583
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N470095002502 followed by a unit qualifier and the quantity

Package 70095-0025-02. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 70095-025

What is NDC 70095-025?: 70095-025 is the product NDC for Azithromycin monohydrate, Azithromycin monohydrate 500 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Azithromycin monohydrate.
What is the active ingredient?: Azithromycin monohydrate.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 70095. 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 monohydrate?: 1 other product NDC are listed under this name. See all Azithromycin monohydrate 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 monohydrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Azithromycin monohydrate	Azithromycin monohydrate 500 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Gland Pharma Limited	68083-199	68083-0199-10

Other NDCs under ANDA 065501

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

FDA NDC Directory listings under ANDA 065501
Product	Strength	Form · route	Labeler	Product NDC
Azithromycinazithromycin monohydrate	Azithromycin monohydrate 500 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-180
Azithromycinazithromycin monohydrate	Azithromycin monohydrate 500 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Athenex Pharmaceutical Division, LLC.	70860-100
Azithromycinazithromycin monohydrate	Azithromycin monohydrate 500 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Athenex Pharmaceutical Division, LLC.	70860-125
Azithromycin monohydrate	Azithromycin monohydrate 500 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Gland Pharma Limited	68083-199