Over-the-counter drug · ANDA

Naproxen Sodium NDC 68210-4096

Naproxen sodium 220 mg/1 · Tablet, Film coated, Extended release · Oral · SPIRIT PHARMACEUTICALS,LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)68210-4096Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68210-4096Add 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
68210-4096-16821040960168210409601365 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68210-4096-1)Marketed from Jul 2, 2020

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 — 220 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
SPIRIT PHARMACEUTICALS,LLCNDC labeler code 68210
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091353
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 68210-4096_2a8235d0-4618-0572-e063-6394a90a0d1aSPL ID 2a8235d0-4618-0572-e063-6394a90a0d1aSPL set ID a690dc39-95f2-4853-a291-05d7dc9a1551UNII 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

N468210409601 followed by a unit qualifier and the quantity

Package 68210-4096-01. 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)

Uses temporarily relieves minor aches and pain due to : backache headache menstrul cramps minor pain of arthritis muscular aches the common cold toothache temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68210-4096

What is NDC 68210-4096?
68210-4096 is the product NDC for Naproxen Sodium, Naproxen sodium 220 mg/1 tablet, film coated, extended release, listed with the FDA by SPIRIT PHARMACEUTICALS,LLC. 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?
SPIRIT PHARMACEUTICALS,LLC, NDC labeler code 68210. 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 091353

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

FDA NDC Directory listings under ANDA 091353
ProductStrengthForm · routeLabelerProduct NDC
Pain Reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralGobrands, Inc82501-1576
All Day Pain Reliefnaproxen sodium tablets, 220 mgNaproxen sodium 220 mg/1TabletOralHealthLife of USA LLC69517-109
Dr Simi All Day Pain Reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralFarmacias De Similares TX LLC85786-104
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralTARGET CORPORATION11673-764
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralSafeway, Inc21130-061
NaproxenNaproxen sodium 220 mg/1TabletOralSafeway, Inc21130-062
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralBi-Mart37835-594
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralGranules India Ltd62207-327
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralGranules India Ltd62207-328
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralCVS51316-761
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralCVS51316-762
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralGranules India Ltd62207-728
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralGranules India Ltd62207-729
Rapidol Naproxennaproxen sodiumNaproxen sodium 220 mg/1Tablet, CoatedOralPharmadel LLC55758-048
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralGranules India Ltd62207-761
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralGranules India Ltd62207-762
Proxen Np 660naproxen sodiumNaproxen sodium 220 mg/1TabletOralOPMX LLC69729-123
Naproxen SodiumNaproxen sodium 220 mg/1TabletOralGranules USA, Inc.69848-010

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