What is NDC 43598-171?

43598-171 is the product NDC for Thiotepa, Thiotepa 100 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Dr.Reddy's Laboratories Inc.,. It has 1 package NDC, shown above in 10- and 11-digit form.

Dr.Reddy's Laboratories Inc.,, NDC labeler code 43598. 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 43598-171 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-171Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0171Add 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
43598-171-11	4359801711143598017111	1 VIAL in 1 CARTON (43598-171-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Nov 1, 2022

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, Lyophilized, For solution
Route: Intracavitary, Intravenous, Intravesical
Labeler: Dr.Reddy's Laboratories Inc.,NDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214222
Marketing start: Nov 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 43598-171_f413a54f-b61e-c888-c7cc-75bd839b108aSPL ID f413a54f-b61e-c888-c7cc-75bd839b108aSPL set ID a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bbRxCUI 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

N443598017111 followed by a unit qualifier and the quantity

Package 43598-0171-11. 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 Nov 1, 2022. 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 secondaryto diffuse or localized neoplastic diseases of various serosal cavities. (1.3) For treatmentof 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 Bladder …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-171

What is NDC 43598-171?: 43598-171 is the product NDC for Thiotepa, Thiotepa 100 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Dr.Reddy's Laboratories 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?: Dr.Reddy's Laboratories Inc.,, NDC labeler code 43598. 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	Hikma Pharmaceuticals USA Inc.	0143-9292	00143-9292-01
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

Other NDCs under ANDA 214222

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

FDA NDC Directory listings under ANDA 214222
Product	Strength	Form · route	Labeler	Product NDC
Thiotepa	Thiotepa 100 mg/1	Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical	Fresenius Kabi USA, LLC	65219-029
Thiotepa	Thiotepa 15 mg/1	Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical	Gland Pharma Limited	68083-446
Thiotepa	Thiotepa 100 mg/1	Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical	Gland Pharma Limited	68083-503