NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1650Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1650Add 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
71335-1650-071335165000713351650006 TABLET, FILM COATED in 1 BOTTLE (71335-1650-0)Marketed from Aug 12, 2024
71335-1650-1713351650017133516500120 TABLET, FILM COATED in 1 BOTTLE (71335-1650-1)Marketed from Aug 12, 2024
71335-1650-27133516500271335165002100 TABLET, FILM COATED in 1 BOTTLE (71335-1650-2)Marketed from Aug 12, 2024
71335-1650-3713351650037133516500330 TABLET, FILM COATED in 1 BOTTLE (71335-1650-3)Marketed from Jun 23, 2020
71335-1650-47133516500471335165004120 TABLET, FILM COATED in 1 BOTTLE (71335-1650-4)Marketed from Aug 12, 2024
71335-1650-5713351650057133516500560 TABLET, FILM COATED in 1 BOTTLE (71335-1650-5)Marketed from Aug 12, 2024
71335-1650-6713351650067133516500690 TABLET, FILM COATED in 1 BOTTLE (71335-1650-6)Marketed from Aug 12, 2024
71335-1650-7713351650077133516500742 TABLET, FILM COATED in 1 BOTTLE (71335-1650-7)Marketed from Aug 12, 2024
71335-1650-8713351650087133516500814 TABLET, FILM COATED in 1 BOTTLE (71335-1650-8)Marketed from Aug 12, 2024
71335-1650-9713351650097133516500956 TABLET, FILM COATED in 1 BOTTLE (71335-1650-9)Marketed from Aug 12, 2024

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)
Naproxen sodium
Generic name (nonproprietary)
naproxen sodium
Active ingredients
Naproxen sodium — 550 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078486
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 71335-1650_2bd1f190-c76c-4003-9ab9-1c6c27dde97aSPL ID 2bd1f190-c76c-4003-9ab9-1c6c27dde97aSPL set ID 42f6a3a0-5a1e-40ca-8949-b8870dd95d2eRxCUI 849431UNII 9TN87S3A3C

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

N471335165000 followed by a unit qualifier and the quantity

Package 71335-1650-00. 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 tablets are indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • Polyarticular Juvenile Idiopathic Arthritis Naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: • tendonitis • bursitis • acute gout the management of: • pain • primary dysmenorrhea Naproxen sodium tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • polyarticular juvenile idiopathic arthritis Naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: • tendonitis • b…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1650

What is NDC 71335-1650?
71335-1650 is the product NDC for Naproxen sodium, Naproxen sodium 550 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 ANDA 078486

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

FDA NDC Directory listings under ANDA 078486
ProductStrengthForm · routeLabelerProduct NDC
Naproxen sodiumNaproxen sodium 275 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc.43598-494
Naproxen sodiumNaproxen sodium 550 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc.43598-495
Naproxen sodiumNaproxen sodium 550 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5238
Naproxen sodiumNaproxen sodium 550 mg/1Tablet, Film coatedOralQuality Care Products, LLC55700-625
Naproxen sodiumNaproxen sodium 550 mg/1Tablet, Film coatedOralPHOENIX RX LLC85509-1495

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