What is NDC 0338-9053?

0338-9053 is the product NDC for Micafungin in Sodium Chloride, Micafungin sodium 100 mg/100mL injection, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

Baxter Healthcare Corporation, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Micafungin in Sodium Chloride?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Micafungin in Sodium Chloride NDC 0338-9053

NDC codes

FDA NDC Directory

Product NDC (as listed)0338-9053Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00338-9053Add 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
0338-9053-12	00338905312	12 CARTON in 1 CARTON (0338-9053-12) / 1 BAG in 1 CARTON (0338-9053-01) / 100 mL in 1 BAGMarketed from Sep 29, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Micafungin in Sodium Chloride
Generic name (nonproprietary): micafungin in sodium chloride
Active ingredients: Micafungin sodium — 100 mg/100mL
Dosage form: Injection
Route: Intravenous
Labeler: Baxter Healthcare CorporationNDC labeler code 0338
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 216142
Marketing start: Sep 29, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Lipopeptides (Chemical structure)
Identifiers: Product ID 0338-9053_ea0ba620-0d2f-4cda-bf7f-90657997dc49SPL ID ea0ba620-0d2f-4cda-bf7f-90657997dc49SPL set ID a95f901e-0ac4-4ec0-9720-9c6a066cd06cRxCUI 2667650, 2667652, 2667653UNII IS1UP79R56
Pharmacologic class: Echinocandin Antifungal

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

N400338905312 followed by a unit qualifier and the quantity

Package 00338-9053-12. 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 Sep 29, 2023.

Indications (excerpt from the label)

Micafungin in Sodium Chloride Injection is indicated for: • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved [ see Clinical Studies (14.1) and Use in Specific Populations (8.4) ]. • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved [ see Use in Specific Populations (8.4) ]. • Treatment of Esophageal Candidiasis in adul…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0338-9053

What is NDC 0338-9053?: 0338-9053 is the product NDC for Micafungin in Sodium Chloride, Micafungin sodium 100 mg/100mL injection, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Micafungin in Sodium Chloride.
What is the active ingredient?: Micafungin sodium.
Who is the labeler?: Baxter Healthcare Corporation, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Micafungin in Sodium Chloride?: 2 other product NDCs are listed under this name. See all Micafungin in Sodium Chloride 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 Micafungin in Sodium Chloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Micafungin in Sodium Chloride	Micafungin sodium 50 mg/50mL	InjectionIntravenous	Baxter Healthcare Corporation	0338-9051	00338-9051-12
Micafungin in Sodium Chloride	Micafungin sodium 150 mg/150mL	InjectionIntravenous	Baxter Healthcare Corporation	0338-9055	00338-9055-10

Other NDCs under NDA 216142

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

FDA NDC Directory listings under NDA 216142
Product	Strength	Form · route	Labeler	Product NDC
Micafungin in Sodium Chloride	Micafungin sodium 50 mg/50mL	InjectionIntravenous	Baxter Healthcare Corporation	0338-9051
Micafungin in Sodium Chloride	Micafungin sodium 150 mg/150mL	InjectionIntravenous	Baxter Healthcare Corporation	0338-9055