Prescription drug · NDA
ParaGard T 380A (Copper) NDC 59365-5128
Copper 313.4 mg/1 · Intrauterine device · Intrauterine · CooperSurgical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59365-5128-1 | 5936551280159365512801 | 1 POUCH in 1 CARTON (59365-5128-1) / 1 INTRAUTERINE DEVICE in 1 POUCHMarketed from Nov 2, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- ParaGard T 380A
- Generic name (nonproprietary)
- copper
- Active ingredients
- Copper — 313.4 mg/1
- Dosage form
- Intrauterine device
- Route
- Intrauterine
- Labeler
- CooperSurgical, Inc.NDC labeler code 59365
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018680
- Marketing start
- Listing expires
- Other FDA classes
- Copper (Chemical structure)Decreased Embryonic Implantation (Physiologic effect)Decreased Sperm Motility (Physiologic effect)Inhibit Ovum Fertilization (Physiologic effect)
- Identifiers
- Product ID 59365-5128_3600f263-199c-4589-b51c-92e0185ab0d0SPL ID 3600f263-199c-4589-b51c-92e0185ab0d0SPL set ID 5ea7ce51-b87a-485e-b841-99466a07a4b2RxCUI 2267305, 2267310UNII 789U1901C5
- Pharmacologic class
- Copper-containing Intrauterine Device
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.
- NDC on a medical claim
N459365512801followed by a unit qualifier and the quantityPackage 59365-5128-01. 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)
Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. Paragard is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 59365-5128
- What is NDC 59365-5128?
- 59365-5128 is the product NDC for ParaGard T 380A (copper), Copper 313.4 mg/1 intrauterine device, listed with the FDA by CooperSurgical, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ParaGard T 380A (Copper).
- What is the active ingredient?
- Copper.
- Who is the labeler?
- CooperSurgical, Inc., NDC labeler code 59365. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for ParaGard T 380A?
- 1 other product NDC are listed under this name. See all ParaGard T 380A NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other ParaGard T 380A products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| ParaGard T 380Acopper | Copper 313.4 mg/1 | Intrauterine deviceIntrauterine | CooperSurgical, Inc. | 59365-5129 | 59365-5129-01 |
Other NDCs under NDA 018680
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 |
|---|---|---|---|---|
| ParaGard T 380Acopper | Copper 313.4 mg/1 | Intrauterine deviceIntrauterine | CooperSurgical, Inc. | 59365-5129 |