NDC 0113-4368OTC monographFDA ANDA · ANDA074661

Good Sense Naproxen Sodium

Active substance: Naproxen Sodium

FDA labeler: L. Perrigo Company

7 formulations • 30 package configurations
All 37 registered NDCs — click to copy
In one line

Good Sense Naproxen Sodium (Naproxen Sodium) NDC 0113-4368 converts to 00113-4368-62 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

openFDA Live Registry SyncHIPAA 5-4-2 StandardCMS Level II Crosswalk
Listing: 0113-4368
Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

Reimbursement channel
NDC direct
Oral / Topical formulation billed directly via 11-Digit NDC (No HCPCS J-Code required).
Standard pharmacy claim — no J-Code required
11-digit HIPAA NDC
00113-4368-62
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
Self-Administered (Oral)
Dispensed via retail/mail pharmacy. No clinical administration procedure (CPT) required.
UB-04 revenue code
Rev 0250
0250 (General Pharmacy)
Qualifier: UN
Complete drug registry

All registered strengths & packaging

Every registered strength and package for Good Sense Naproxen Sodium, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
220 mg/10113-4368-620113-436800113-4368-621 BOTTLE in 1 CARTON (0113-4368-62) / 24 TABLET, FILM COATED in 1 BOTTLE
220 mg/10113-4368-710113-436800113-4368-711 BOTTLE in 1 CARTON (0113-4368-71) / 50 TABLET, FILM COATED in 1 BOTTLE
220 mg/10113-4368-750113-436800113-4368-751 BOTTLE in 1 CARTON (0113-4368-75) / 90 TABLET, FILM COATED in 1 BOTTLE
220 mg/10113-4368-790113-436800113-4368-79400 TABLET, FILM COATED in 1 BOTTLE (0113-4368-79)
220 mg/10113-4368-820113-436800113-4368-821 BOTTLE in 1 CARTON (0113-4368-82) / 200 TABLET, FILM COATED in 1 BOTTLE (0113-4368-00)
Inner component0113-4368-000113-436800113-4368-00Inner component of kit (0113-4368-82)
220 mg/163187-794-2063187-79463187-0794-2020 TABLET, FILM COATED in 1 BOTTLE (63187-794-20)
220 mg/163187-794-3063187-79463187-0794-3030 TABLET, FILM COATED in 1 BOTTLE (63187-794-30)
220 mg/163187-794-6063187-79463187-0794-6060 TABLET, FILM COATED in 1 BOTTLE (63187-794-60)
220 mg/10113-0901-620113-090100113-0901-621 BOTTLE in 1 CARTON (0113-0901-62) / 24 TABLET, FILM COATED in 1 BOTTLE
220 mg/10113-0901-710113-090100113-0901-711 BOTTLE in 1 CARTON (0113-0901-71) / 50 TABLET, FILM COATED in 1 BOTTLE
220 mg/10113-0901-750113-090100113-0901-751 BOTTLE in 1 CARTON (0113-0901-75) / 90 TABLET, FILM COATED in 1 BOTTLE
220 mg/10113-1412-710113-141200113-1412-711 BOTTLE in 1 CARTON (0113-1412-71) / 50 TABLET, FILM COATED in 1 BOTTLE
25 mg/1, 220 mg/10113-8264-060113-826400113-8264-061 BOTTLE in 1 CARTON (0113-8264-06) / 160 TABLET, FILM COATED in 1 BOTTLE (0113-8264-00)
Inner component0113-8264-000113-826400113-8264-00Inner component of kit (0113-8264-06)
25 mg/1, 220 mg/10113-8264-600113-826400113-8264-601 BOTTLE in 1 CARTON (0113-8264-60) / 20 TABLET, FILM COATED in 1 BOTTLE
25 mg/1, 220 mg/10113-8264-710113-826400113-8264-711 BOTTLE in 1 CARTON (0113-8264-71) / 50 TABLET, FILM COATED in 1 BOTTLE
220 mg/171335-2584-171335-258471335-2584-0120 TABLET, FILM COATED in 1 BOTTLE (71335-2584-1)
220 mg/171335-2584-271335-258471335-2584-0230 TABLET, FILM COATED in 1 BOTTLE (71335-2584-2)
220 mg/171335-2584-371335-258471335-2584-0340 TABLET, FILM COATED in 1 BOTTLE (71335-2584-3)
220 mg/171335-2584-471335-258471335-2584-0450 TABLET, FILM COATED in 1 BOTTLE (71335-2584-4)
220 mg/171335-2584-571335-258471335-2584-0560 TABLET, FILM COATED in 1 BOTTLE (71335-2584-5)
220 mg/171335-2584-671335-258471335-2584-0614 TABLET, FILM COATED in 1 BOTTLE (71335-2584-6)
220 mg/171335-2584-771335-258471335-2584-07100 TABLET, FILM COATED in 1 BOTTLE (71335-2584-7)
220 mg/171335-2584-871335-258471335-2584-0890 TABLET, FILM COATED in 1 BOTTLE (71335-2584-8)
220 mg/171335-2584-971335-258471335-2584-0924 TABLET, FILM COATED in 1 BOTTLE (71335-2584-9)
220 mg/168788-8443-268788-844368788-8443-0220 TABLET, FILM COATED in 1 BOTTLE (68788-8443-2)
220 mg/168788-8443-368788-844368788-8443-0330 TABLET, FILM COATED in 1 BOTTLE (68788-8443-3)
220 mg/168788-8443-468788-844368788-8443-0440 TABLET, FILM COATED in 1 BOTTLE (68788-8443-4)
220 mg/168788-8443-668788-844368788-8443-0660 TABLET, FILM COATED in 1 BOTTLE (68788-8443-6)
FDA drug label

Prescribing information

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary.

3 Label Sections
Uses • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • temporarily reduces fever
Directions • do not take more than directed • the smallest effective dose should be used • drink a full glass of water with each dose Adults and children 12 years and older • take 1 caplet every 8 to 12 hours while symptoms last • for the first dose you may take 2 caplets within the first hour • do not exceed 2 caplets in any 8- to 12-hour period • do not exceed 3 caplets in a 24-hour period Children under 12 years • ask a doctor
Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery Ask a doctor before use if • the stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke • you are taking a diuretic • you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin • taking any other drug When using this product • take with food or milk if stomach upset occurs Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • you have difficulty swallowing • it feels like the pill is stuck in your throat • redness or swelling is present in the painful area • any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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