NDC codes

FDA NDC Directory
Product NDC (as listed)47335-410Labeler and product segments. Claims need a package NDC.
Product NDC at billing width47335-0410Add 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
47335-410-22473350410229 TABLET, FILM COATED in 1 BOTTLE (47335-410-22)Marketed from Jul 20, 2018
47335-410-834733504108330 TABLET, FILM COATED in 1 BOTTLE (47335-410-83)Marketed from Jul 20, 2018
47335-410-8847335041088100 TABLET, FILM COATED in 1 BOTTLE (47335-410-88)Marketed from Jul 20, 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)
Sumatriptan and Naproxen Sodium
Generic name (nonproprietary)
sumatriptan and naproxen sodium
Active ingredients
Sumatriptan succinate — 85 mg/1Naproxen sodium — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202803
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers
Product ID 47335-410_c67d3234-28c7-40a9-a472-87747bb4242aSPL ID c67d3234-28c7-40a9-a472-87747bb4242aSPL set ID 96ed12a3-fa76-4afd-bee8-1ab19eb607f3RxCUI 849450UNII J8BDZ68989, 9TN87S3A3CUPC 0347335410228
Pharmacologic class
Nonsteroidal Anti-inflammatory Drug; Serotonin-1b and Serotonin-1d Receptor Agonist

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N447335041022 followed by a unit qualifier and the quantity

Package 47335-0410-22. 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)

Sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan and naproxen sodium tablets, reconsider the diagnosis of migraine before sumatriptan and naproxen sodium tablets are administered to treat any subsequent attacks. Sumatriptan and naproxen sodium tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan and naproxen sodium tablets have not been established…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47335-410

What is NDC 47335-410?
47335-410 is the product NDC for Sumatriptan and Naproxen Sodium, Sumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sumatriptan and Naproxen Sodium.
What is the active ingredient?
Sumatriptan succinate, Naproxen sodium.
Who is the labeler?
Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sumatriptan and Naproxen Sodium?
2 other product NDCs are listed under this name. See all Sumatriptan and Naproxen Sodium NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sumatriptan and Naproxen Sodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sumatriptan and Naproxen SodiumSumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1Tablet, Film coatedOralNorthStar RxLLC16714-89116714-0891-01
Sumatriptan and Naproxen SodiumSumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-92865862-0928-36

Other NDCs under ANDA 202803

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

FDA NDC Directory listings under ANDA 202803
ProductStrengthForm · routeLabelerProduct NDC
Sumatriptan and Naproxen SodiumSumatriptan succinate 85 mg/1; Naproxen sodium 500 mg/1Tablet, Film coatedOralNorthStar RxLLC16714-891

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