Thiotepa NDC 71288-157

NDC codes

FDA NDC Directory

Product NDC (as listed)71288-157Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71288-0157Add 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
71288-157-10	71288015710	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-157-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Dec 26, 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): Thiotepa
Generic name (nonproprietary): thiotepa
Active ingredients: Thiotepa — 100 mg/1
Dosage form: Injection, Powder, For solution
Route: Intracavitary, Intravenous, Intravesical
Labeler: Meitheal Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216037
Marketing start: Dec 26, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 71288-157_d75a277e-a2ff-4409-8ef3-34b7fd2198f1SPL ID d75a277e-a2ff-4409-8ef3-34b7fd2198f1SPL set ID 4b4725eb-95f1-45cc-852f-152beb5f1e2cRxCUI 1660004, 1660009UNII 905Z5W3GKH
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.

How CPT relates to drug billing

NDC on a medical claim

N471288015710 followed by a unit qualifier and the quantity

Package 71288-0157-10. 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 Dec 27, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Thiotepa for Injection is an alkylating drug indicated: For treatment of adenocarcinoma of the breast or ovary. ( 1.2 ) For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. ( 1.3 ) For treatment of superficial papillary carcinoma of the urinary bladder. ( 1.4 ) 1.2 Adenocarcinoma of the Breast or Ovary Thiotepa for Injection is indicated for treatment of adenocarcinoma of the breast or ovary. 1.3 Malignant Effusions Thiotepa for Injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. 1.4 Superficial Papillary Carcinoma of the Urinary …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216037

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

FDA NDC Directory listings under ANDA 216037
Product	Strength	Form · route	Labeler	Product NDC
Thiotepa	Thiotepa 15 mg/1	Injection, Powder, For solutionIntracavitary, Intravenous, Intravesical	Meitheal Pharmaceuticals Inc	71288-156