Prescription drug · ANDA
Gemcitabine (Gemcitabine hydrochloride) NDC 16714-909
Gemcitabine hydrochloride 200 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-909-01 | 1671409090116714090901 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-909-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Nov 1, 2018 |
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 — 200 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- NorthStar Rx LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091365
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 16714-909_3907fd14-53af-499a-8334-94adb74142e0SPL ID 3907fd14-53af-499a-8334-94adb74142e0SPL set ID 5af49a48-f1c0-467d-b5da-ac9f1ae8e34cRxCUI 1719000, 1719003UNII U347PV74ILUPC 0316714930015
- 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
N416714090901followed by a unit qualifier and the quantityPackage 16714-0909-01. 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 .
Indications (excerpt from the label)
Gemcitabine for injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin, for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine for injection in combination with carboplatin is indicate…
Excerpt only. Read the full label for complete information.
About NDC 16714-909
- What is NDC 16714-909?
- 16714-909 is the product NDC for Gemcitabine (gemcitabine hydrochloride), Gemcitabine hydrochloride 200 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by NorthStar Rx LLC. It has 1 package NDC, 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?
- NorthStar Rx LLC, NDC labeler code 16714. 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 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 |
| Gemcitabinegemcitabine hydrochloride | Gemcitabine hydrochloride 1 g/26.3mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-617 | 67457-0617-30 |
Other NDCs under ANDA 091365
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 1 g/1 | Injection, Powder, Lyophilized, For solutionIntravenous | NorthStar Rx LLC | 16714-930 |
| gemcitabine | Gemcitabine hydrochloride 200 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Dr. Reddy's Laboratories Limited | 55111-686 |
| gemcitabine | Gemcitabine hydrochloride 1 g/25mL | Injection, Powder, Lyophilized, For solutionIntravenous | Dr. Reddy's Laboratories Limited | 55111-687 |
| Gemcitabinegemcitabine hydrochloride | Gemcitabine hydrochloride 200 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-113 |
| Gemcitabinegemcitabine hydrochloride | Gemcitabine hydrochloride 1 g/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-114 |