Over-the-counter drug · ANDA

Flanax Pain Reliever/Fever Reducer (Naproxen sodium) NDC 67751-125

Naproxen sodium 220 mg/1 · Tablet · Oral · Navajo Manufacturing Company Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)67751-125Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67751-0125Add 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
67751-125-0167751012501677510125011 PACKET in 1 CARTON (67751-125-01) / 2 TABLET in 1 PACKETMarketed from Jul 20, 2020

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)
Flanax Pain Reliever/Fever Reducer
Generic name (nonproprietary)
naproxen sodium
Active ingredients
Naproxen sodium — 220 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Navajo Manufacturing Company Inc.NDC labeler code 67751
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090545
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 67751-125_f706ab57-bb88-8e63-e053-6394a90a99c0SPL ID f706ab57-bb88-8e63-e053-6394a90a99c0SPL set ID f706b406-58f2-9b82-e053-6394a90ab598RxCUI 849574UNII 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

N467751012501 followed by a unit qualifier and the quantity

Package 67751-0125-01. 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 pains due to: ■ backache ■ muscular aches ■ minor pain of arthritis ■ menstrual cramps ■ headache ■ toothache ■ the common cold Temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67751-125

What is NDC 67751-125?
67751-125 is the product NDC for Flanax Pain Reliever/Fever Reducer, Naproxen sodium 220 mg/1 tablet, listed with the FDA by Navajo Manufacturing Company Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Flanax Pain Reliever/Fever Reducer (Naproxen Sodium).
What is the active ingredient?
Naproxen sodium.
Who is the labeler?
Navajo Manufacturing Company Inc., NDC labeler code 67751. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Flanax Pain Reliever/Fever Reducer?
2 other product NDCs are listed under this name. See all Flanax Pain Reliever/Fever Reducer 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 Flanax Pain Reliever/Fever Reducer NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Flanax Pain Reliever/Fever reducernaproxen sodiumNaproxen sodium 220 mg/1Tablet, CoatedOralBelmora LLC27854-50527854-0505-0127854-0505-02
Flanax Pain Reliever/Fever Reducernaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralBelmora LLC27854-70027854-0700-0127854-0700-1027854-0700-99

Other NDCs under ANDA 090545

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

FDA NDC Directory listings under ANDA 090545
ProductStrengthForm · routeLabelerProduct NDC
Naproxen Sodium 220mgNaproxen sodium 220 mg/1Tablet, Film coatedOralGrocery Outlet85828-394
All Day Pain Reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, CoatedOralWALGREENS0363-6099
Naproxen Sodiumnaproxen sodium, coated tabletsNaproxen sodium 220 mg/1TabletOralMARKSANS PHARMA LIMITED25000-141
Naproxen Sodiumnaproxen sodium tablet, coatedNaproxen sodium 220 mg/1TabletOralMARKSANS PHARMA LIMITED25000-144
Calmadol Pain Relievernaproxen sodiumNaproxen sodium 220 mg/1TabletOralGRANDALL DISTRIBUTING, LLC48201-007
Naproxen Caplets All day relief for painnaproxen sodium 220 mgNaproxen sodium 220 mg/1TabletOralAllegiant Health69168-362
Naproxen Sodium 220mgNaproxen sodium 220 mg/1Tablet, CoatedOralAllegiant Health69168-395
Naproxen Capletsnaproxen sodium 220 mgNaproxen sodium 220 mg/1TabletOralAllegiant Health69168-394
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralKroger Company41226-609
Flanax Pain Reliever/Fever reducernaproxen sodiumNaproxen sodium 220 mg/1Tablet, CoatedOralBelmora LLC27854-505
Belmora Flanaxnaproxen sodiumNaproxen sodium 220 mg/1TabletOralBelmora LLC27854-555
All Day Pain Reliefnaproxen sodiumNaproxen sodium 220 mg/1TabletOralWalmart Inc.79903-389
Naproxen Sodium 220mgNaproxen sodium 220 mg/1Tablet, CoatedOralCommand Brands, LLC69197-394
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralTIME CAP LABORATORIES, INC49483-608
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralTIME CAP LABORATORIES, INC49483-609
All Day Pain Reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, CoatedOralWALGREENS0363-9608
Back And Muscle PainnaproxenNaproxen sodium 220 mg/1Tablet, CoatedOralWALGREENS0363-9609
Pain Reliefnaproxen sodiumNaproxen sodium 220 mg/1TabletOralBETTER LIVING BRANDS, LLC21130-608
All Day Back and Muscle Pain Reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, CoatedOralWalmart Inc.79903-609
Naproxen Sodium 220mgNaproxen sodium 220 mg/1Tablet, CoatedOralAthlete's Needs, Inc.53185-394

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