Prescription drug · NDA
Ifex (Ifosfamide) NDC 0338-3991
Ifosfamide 1 g/20mL · Injection, Powder, For solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-3991-01 | 00338399101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-3991-01) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 30, 1988 |
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)
- Ifex
- Generic name (nonproprietary)
- ifosfamide
- Active ingredients
- Ifosfamide — 1 g/20mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019763
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 0338-3991_56f50d8e-7c87-4119-a7dc-bfd77fa3dcecSPL ID 56f50d8e-7c87-4119-a7dc-bfd77fa3dcecSPL set ID b7241707-7538-4d1a-91e7-3a25a91e0b9aRxCUI 1791588, 1791591, 1791593, 1791595UNII UM20QQM95Y
- Pharmacologic class
- Alkylating Drug
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.
- NDC on a medical claim
N400338399101followed by a unit qualifier and the quantityPackage 00338-3991-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
IFEX is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. IFEX is an alkylating drug indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
Excerpt only. Read the full label for complete information.
About NDC 0338-3991
- What is NDC 0338-3991?
- 0338-3991 is the product NDC for Ifex (ifosfamide), Ifosfamide 1 g/20mL injection, powder, for solution, 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?
- Ifex (Ifosfamide).
- What is the active ingredient?
- Ifosfamide.
- 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 Ifex?
- 1 other product NDC are listed under this name. See all Ifex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ifex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ifexifosfamide | Ifosfamide 3 g/60mL | Injection, Powder, For solutionIntravenous | Baxter Healthcare Corporation | 0338-3993 | 00338-3993-01 |
Other NDCs under NDA 019763
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ifexifosfamide | Ifosfamide 3 g/60mL | Injection, Powder, For solutionIntravenous | Baxter Healthcare Corporation | 0338-3993 |
| Ifosfamide | Ifosfamide 1 g/20mL | Injection, Powder, For solutionIntravenous | Baxter Healthcare Company | 10019-925 |
| Ifosfamide | Ifosfamide 3 g/60mL | Injection, Powder, For solutionIntravenous | Baxter Healthcare Company | 10019-926 |
| Ifosfamide | Ifosfamide 1 g/20mL | Injection, Powder, For solutionIntravenous | Baxter Healthcare Company | 10019-927 |
| Ifosfamide | Ifosfamide 3 g/60mL | Injection, Powder, For solutionIntravenous | Baxter Healthcare Company | 10019-929 |