What is NDC 68083-446?

68083-446 is the product NDC for Thiotepa, Thiotepa 15 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. 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 68083-446 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-446Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0446Add 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
68083-446-01	6808304460168083044601	1 VIAL in 1 CARTON (68083-446-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Mar 8, 2021

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 — 15 mg/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intracavitary, Intravenous, Intravesical
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214222
Marketing start: Mar 8, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 68083-446_164faf7b-519a-41f7-a760-eb2a81b9f040SPL ID 164faf7b-519a-41f7-a760-eb2a81b9f040SPL set ID 6cd6ae89-c553-4328-9262-4363610a1f19RxCUI 1660004, 1660009UNII 905Z5W3GKHUPC 0368083503017
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

N468083044601 followed by a unit qualifier and the quantity

Package 68083-0446-01. 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 Jan 23, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Thiotepa for injection is an alkylating drug indicated: • To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. ( 1.1 , 14 ) • 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 ) 1.1 Class 3 Beta-Thalassemia Thiotepa for injection is indicated to reduce the risk o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-446

What is NDC 68083-446?: 68083-446 is the product NDC for Thiotepa, Thiotepa 15 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. 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?: Gland Pharma Limited, NDC labeler code 68083. 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	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	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	Dr.Reddy's Laboratories Inc.,	43598-171
Thiotepa	Thiotepa 100 mg/1	Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical	Fresenius Kabi USA, LLC	65219-029
Thiotepa	Thiotepa 100 mg/1	Injection, Powder, Lyophilized, For solutionIntracavitary, Intravenous, Intravesical	Gland Pharma Limited	68083-503