NDC codes

FDA NDC Directory
Product NDC (as listed)59365-5128Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59365-5128Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
59365-5128-1593655128011 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
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

N459365512801 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 018680

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 018680
ProductStrengthForm · routeLabelerProduct NDC
ParaGard T 380AcopperCopper 313.4 mg/1Intrauterine deviceIntrauterineCooperSurgical, Inc.59365-5129

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