What is NDC 0143-9292?

0143-9292 is the product NDC for Thiotepa, Thiotepa 100 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Thiotepa?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Thiotepa NDC 0143-9292 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0143-9292Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00143-9292Add 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
0143-9292-01	00143929201	1 VIAL in 1 BOX, UNIT-DOSE (0143-9292-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed 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): Thiotepa
Generic name (nonproprietary): thiotepa
Active ingredients: Thiotepa — 100 mg/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intracavitary, Intravenous, Intravesical
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211755
Marketing start: Sep 29, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 0143-9292_f18a13d2-83c0-42a1-8980-60b228c23ab9SPL ID f18a13d2-83c0-42a1-8980-60b228c23ab9SPL set ID 9ae8063c-ba28-4da2-a94c-8e1a5f75e4b3RxCUI 1660004UNII 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

N400143929201 followed by a unit qualifier and the quantity

Package 00143-9292-01. 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 May 31, 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)

About NDC 0143-9292

What is NDC 0143-9292?: 0143-9292 is the product NDC for Thiotepa, Thiotepa 100 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Thiotepa.
What is the active ingredient?: Thiotepa.
Who is the labeler?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Thiotepa?: 12 other product NDCs are listed under this name. See all Thiotepa 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 Thiotepa NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Thiotepa	Thiotepa 15 mg/1	Injection, Powder, For solutionIntracavitary, Intravenous, Intravesical	Meitheal Pharmaceuticals Inc	71288-156	71288-0156-05
Thiotepa	Thiotepa 100 mg/1	Injection, Powder, For solutionIntracavitary, Intravenous, Intravesical	Meitheal Pharmaceuticals Inc	71288-157	71288-0157-10
Thiotepa	Thiotepa 100 mg/1	Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical	Dr.Reddy's Laboratories Inc.,	43598-171	43598-0171-11
Thiotepa	Thiotepa 100 mg/1	Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical	Fresenius Kabi USA, LLC	65219-029	65219-0029-20
Thiotepa	Thiotepa 100 mg/1	Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical	Gland Pharma Limited	68083-503	68083-0503-01
Thiotepa	Thiotepa 15 mg/1	Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical	Gland Pharma Limited	68083-446	68083-0446-01
Thiotepa	Thiotepa 15 mg/1	Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical	Novadoz Pharmaceuticals LLC	72205-045	72205-0045-01
Thiotepa	Thiotepa 100 mg/1	Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical	Novadoz Pharmaceuticals LLC	72205-046	72205-0046-01
Thiotepa	Thiotepa 15 mg/1.5mL	Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical	Sagent Pharmaceuticals	25021-246	25021-0246-02
Thiotepa	Thiotepa 15 mg/1	Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical	Dr.Reddy's Laboratories Inc.,	43598-650	43598-0650-11

All 13 Thiotepa NDCs