NDC codes

FDA NDC Directory
Product NDC (as listed)47781-153Labeler and product segments. Claims need a package NDC.
Product NDC at billing width47781-0153Add 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
47781-153-014778101530147781015301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47781-153-01)Marketed from Mar 11, 2015

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)
Naproxen Sodium
Generic name (nonproprietary)
naproxen sodium
Active ingredients
Naproxen sodium — 375 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Alvogen Inc.NDC labeler code 47781
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 020353
Marketing start
Marketing end
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 47781-153_6a207289-a8f0-9db1-548f-b55af6131677SPL ID 6a207289-a8f0-9db1-548f-b55af6131677SPL set ID 9225acaa-209f-958b-2c51-9a46995dec33RxCUI 1116320, 1116339, 1116349UNII 9TN87S3A3CUPC 0347781153014, 0347781155308, 0347781154752

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

N447781015301 followed by a unit qualifier and the quantity

Package 47781-0153-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Naproxen Sodium Controlled-Release Tablets are indicated for the treatment of: rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain [ see Warnings and Precautions ( 5 ) ]. Naproxen Sodium Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug indicated for the treatment of: rheumatoid arthritis (RA)( 1 ) osteoarthritis (OA)( 1 ) ankylosing spondylitis (AS)( 1 ) tendinitis, bursitis ( 1 ) acute gout ( 1 ) primary dysmenorrhea (PD)( 1 ) the relief of mild to moderate pain ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47781-153

What is NDC 47781-153?
47781-153 is the product NDC for Naproxen Sodium, Naproxen sodium 375 mg/1 tablet, film coated, extended release, listed with the FDA by Alvogen Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Naproxen Sodium.
What is the active ingredient?
Naproxen sodium.
Who is the labeler?
Alvogen Inc., NDC labeler code 47781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Naproxen Sodium?
144 other product NDCs are listed under this name. See all 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 Naproxen Sodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
naproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-98872288-0988-75
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralAAA Pharmaceutical, Inc.57344-24457344-0244-03
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-057480425-0574-0180425-0574-0280425-0574-03
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralHYVEE INC42507-24542507-0245-0142507-0245-0842507-0245-14
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralHYVEE INC42507-84442507-0844-0142507-0844-14
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralTARGET Corporation11673-65111673-0651-78
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralSafeway21130-59321130-0593-79
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-053180425-0531-0180425-0531-0280425-0531-03
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-053280425-0532-0180425-0532-0280425-0532-03
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-10883324-0108-0183324-0108-2483324-0108-50

All 145 Naproxen Sodium NDCs

Other NDCs under NDA 020353

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

FDA NDC Directory listings under NDA 020353
ProductStrengthForm · routeLabelerProduct NDC
Naprelannaproxen sodiumNaproxen sodium 375 mg/1Tablet, Film coated, Extended releaseOralUpsher-Smith Laboratories, LLC24979-249
Naprelannaproxen sodiumNaproxen sodium 500 mg/1Tablet, Film coated, Extended releaseOralUpsher-Smith Laboratories, LLC24979-250
Naprelannaproxen sodiumNaproxen sodium 750 mg/1Tablet, Film coated, Extended releaseOralUpsher-Smith Laboratories, LLC24979-251
Naprelannaproxen sodiumNaproxen sodium 375 mg/1Tablet, Film coated, Extended releaseOralAlmatica Pharma LLC52427-272
Naprelannaproxen sodiumNaproxen sodium 500 mg/1Tablet, Film coated, Extended releaseOralAlmatica Pharma LLC52427-273
Naproxen SodiumNaproxen sodium 375 mg/1Tablet, Film coated, Extended releaseOralUpsher-Smith Laboratories, LLC24979-252
Naproxen SodiumNaproxen sodium 500 mg/1Tablet, Film coated, Extended releaseOralUpsher-Smith Laboratories, LLC24979-253
Naproxen SodiumNaproxen sodium 500 mg/1Tablet, Film coated, Extended releaseOralAlvogen Inc.47781-154
Naproxen SodiumNaproxen sodium 375 mg/1Tablet, Film coated, Extended releaseOralSA3, LLC69420-1375

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