Prescription drug · ANDA
gemcitabine (Gemcitabine hydrochloride) NDC 25021-235
Gemcitabine hydrochloride 1 g/25mL · Injection, Powder, Lyophilized, For solution · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-235-50 | 2502102355025021023550 | 1 VIAL in 1 CARTON (25021-235-50) / 25 mL in 1 VIALMarketed from Dec 29, 2014 | |
| 25021-235-51 | 2502102355125021023551 | 10 VIAL in 1 CARTON (25021-235-51) / 25 mL in 1 VIALMarketed from Dec 15, 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)
- gemcitabine
- Generic name (nonproprietary)
- gemcitabine hydrochloride
- Active ingredients
- Gemcitabine hydrochloride — 1 g/25mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Sagent PharmaceuticalsNDC labeler code 25021
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202485
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 25021-235_95123b19-2847-4cb8-8736-ecca1399bb81SPL ID 95123b19-2847-4cb8-8736-ecca1399bb81
- Pharmacologic class
- Nucleoside Metabolic Inhibitor
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
N425021023550followed by a unit qualifier and the quantityPackage 25021-0235-50. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 25021-235
- What is NDC 25021-235?
- 25021-235 is the product NDC for gemcitabine (gemcitabine hydrochloride), Gemcitabine hydrochloride 1 g/25mL injection, powder, lyophilized, for solution, listed with the FDA by Sagent Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- gemcitabine (Gemcitabine hydrochloride).
- What is the active ingredient?
- Gemcitabine hydrochloride.
- Who is the labeler?
- Sagent Pharmaceuticals, NDC labeler code 25021. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for gemcitabine?
- 24 other product NDCs are listed under this name. See all gemcitabine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other gemcitabine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gemcitabine | Gemcitabine hydrochloride 38 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9340 | 00143-9340-01 |
| Gemcitabine | Gemcitabine hydrochloride 38 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9341 | 00143-9341-01 |
| Gemcitabine | Gemcitabine hydrochloride 38 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9342 | 00143-9342-01 |
| Gemcitabinegemcitabine hydrochloride | Gemcitabine hydrochloride 38 mg/mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-117 | 71288-0117-0671288-0117-2871288-0117-54 |
| Gemcitabine | Gemcitabine hydrochloride 38 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-239 | 25021-0239-0525021-0239-2625021-0239-52 |
| Gemcitabinegemcitabine hydrochloride | Gemcitabine hydrochloride 200 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | NorthStar Rx LLC | 16714-909 | 16714-0909-01 |
| Gemcitabinegemcitabine hydrochloride | Gemcitabine hydrochloride 1 g/1 | Injection, Powder, Lyophilized, For solutionIntravenous | NorthStar Rx LLC | 16714-930 | 16714-0930-01 |
| Gemcitabinegemcitabine hydrochloride | Gemcitabine hydrochloride 200 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-113 | 71288-0113-10 |
| Gemcitabinegemcitabine hydrochloride | Gemcitabine hydrochloride 1 g/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-114 | 71288-0114-50 |
| Gemcitabinegemcitabine hydrochloride | Gemcitabine hydrochloride 200 mg/5.26mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-616 | 67457-0616-10 |
Other NDCs under ANDA 202485
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 |
|---|---|---|---|---|
| gemcitabinegemcitabine hydrochloride | Gemcitabine hydrochloride 200 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-234 |