Prescription drug · NDA
Fragmin (dalteparin sodium) NDC 0069-0196
Dalteparin sodium 5000 [iU]/.2mL · Injection · Subcutaneous · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0196-02 | 00069019602 | 10 SYRINGE in 1 CARTON (0069-0196-02) / .2 mL in 1 SYRINGE (0069-0196-01)Marketed from Apr 1, 2015 |
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)
- Fragmin
- Generic name (nonproprietary)
- dalteparin sodium
- Active ingredients
- Dalteparin sodium — 5000 [iU]/.2mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020287
- Marketing start
- Listing expires
- Other FDA classes
- Low-Molecular-Weight (Chemical structure)
- Identifiers
- Product ID 0069-0196_af340f13-7954-4974-845d-ae55e0b56512SPL ID af340f13-7954-4974-845d-ae55e0b56512SPL set ID 23527b8b-9b28-4e6d-9751-33b143975ac7RxCUI 978725, 978727, 978733, 978735, 978736, 978737, 978740, 978741, 978744, 978745, 978746, 978747, 978755, 978757, 978777, 978778, 2618839, 2618842UNII 12M44VTJ7B
- Pharmacologic class
- Anti-coagulant; Low Molecular Weight Heparin
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
N400069019602followed by a unit qualifier and the quantityPackage 00069-0196-02. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
FRAGMIN is a low molecular weight heparin (LMWH) indicated for • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction ( 1.1 ) • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness ( 1.2 ) • Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months ( 1.3 ) • Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients from birth (gestationa…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020287
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 |
|---|---|---|---|---|
| Fragmindalteparin sodium | Dalteparin sodium 18000 [iU]/.72mL | InjectionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-0228 |
| Fragmindalteparin sodium | Dalteparin sodium 2500 [iU]/.2mL | InjectionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-0195 |
| Fragmindalteparin sodium | Dalteparin sodium 15000 [iU]/.6mL | InjectionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-0223 |
| Fragmindalteparin sodium | Dalteparin sodium 2500 [iU]/mL | InjectionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-0253 |
| Fragmindalteparin sodium | Dalteparin sodium 10000 [iU]/mL | InjectionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-0217 |
| Fragmindalteparin sodium | Dalteparin sodium 7500 [iU]/.3mL | InjectionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-0206 |
| Fragmindalteparin sodium | Dalteparin sodium 12500 [iU]/.5mL | InjectionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-0220 |
| Fragmindalteparin sodium | Dalteparin sodium 25000 [iU]/mL | InjectionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-0232 |