Prescription drug · NDA
SymlinPen (Pramlintide acetate) NDC 0310-6615
Pramlintide acetate 1000 ug/mL · Injection · Subcutaneous · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-6615-02 | 00310661502 | 2 CARTRIDGE in 1 CARTON (0310-6615-02) / 1.5 mL in 1 CARTRIDGEMarketed from Feb 2, 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)
- SymlinPen
- Generic name (nonproprietary)
- pramlintide acetate
- Active ingredients
- Pramlintide acetate — 1000 ug/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021332
- Marketing start
- Marketing end
- Other FDA classes
- Amylin Agonists (Mechanism)
- Identifiers
- Product ID 0310-6615_a84753f1-6ac5-4a47-a382-29972938ccaaSPL ID a84753f1-6ac5-4a47-a382-29972938ccaaSPL set ID 4aea30ff-eb0d-45c1-b114-3127966328ffRxCUI 861042, 861043, 861044, 861045UNII 726I6TE06G
- Pharmacologic class
- Amylin Analog
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
N400310661502followed by a unit qualifier and the quantityPackage 00310-6615-02. 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)
SYMLIN is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. SYMLIN is an amylin analog indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy (1) .
Excerpt only. Read the full label for complete information.
About NDC 0310-6615
- What is NDC 0310-6615?
- 0310-6615 is the product NDC for SymlinPen (pramlintide acetate), Pramlintide acetate 1000 ug/mL injection, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- SymlinPen (Pramlintide acetate).
- What is the active ingredient?
- Pramlintide acetate.
- Who is the labeler?
- AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for SymlinPen?
- 1 other product NDC are listed under this name. See all SymlinPen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other SymlinPen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| SymlinPenpramlintide acetate | Pramlintide acetate 1000 ug/mL | InjectionSubcutaneous | AstraZeneca Pharmaceuticals LP | 0310-6627 | 00310-6627-02 |
Other NDCs under NDA 021332
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 |
|---|---|---|---|---|
| SymlinPenpramlintide acetate | Pramlintide acetate 1000 ug/mL | InjectionSubcutaneous | AstraZeneca Pharmaceuticals LP | 0310-6627 |