NDC codes

FDA NDC Directory
Product NDC (as listed)64380-807Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64380-0807Add 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
64380-807-066438008070664380080706100 TABLET, FILM COATED in 1 BOTTLE (64380-807-06)Marketed from Aug 24, 2018
64380-807-076438008070764380080707500 TABLET, FILM COATED in 1 BOTTLE (64380-807-07)Marketed from Aug 24, 2018

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)
Ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 800 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Strides Pharma Science LimitedNDC labeler code 64380
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078329
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 64380-807_e19243fc-3b9e-4de9-8874-1a6eb683efe8SPL ID e19243fc-3b9e-4de9-8874-1a6eb683efe8SPL set ID a266a3c6-932f-476f-ae93-48a785c92286RxCUI 197805, 197806, 197807UNII WK2XYI10QMUPC 0364380808060, 0364380809074, 0364380807070

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

N464380080706 followed by a unit qualifier and the quantity

Package 64380-0807-06. 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)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64380-807

What is NDC 64380-807?
64380-807 is the product NDC for Ibuprofen, Ibuprofen 800 mg/1 tablet, film coated, listed with the FDA by Strides Pharma Science Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ibuprofen.
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Strides Pharma Science Limited, NDC labeler code 64380. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ibuprofen?
674 other product NDCs are listed under this name. See all Ibuprofen 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 Ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-478470518-4784-0070518-4784-01
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-478670518-4786-00
IbuprofenIbuprofen 200 mg/1TabletOralFamora Inc87509-000487509-0004-05
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralMedcore LLC82461-72582461-0725-90
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralMedcore LLC82461-72482461-0724-90
IbuprofenIbuprofen 200 mg/1TabletOralAurohealth LLC58602-91358602-0913-1758602-0913-40
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73867877-0738-0167877-0738-0567877-0738-30+3 more
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73767877-0737-0167877-0737-0567877-0737-33+1 more
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73967877-0739-0167877-0739-0567877-0739-30+4 more
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralGOODSENSE50804-18550804-0185-0150804-0185-02

All 675 Ibuprofen NDCs

Other NDCs under ANDA 078329

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

FDA NDC Directory listings under ANDA 078329
ProductStrengthForm · routeLabelerProduct NDC
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8309
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8310
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8311
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5818
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5819
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-596
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralST. MARY'S MEDICAL PARK PHARMACY60760-597
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-808
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-809
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4845
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4887
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4949
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4952
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4968
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5066
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5228
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8531
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8710
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC69238-1101
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC69238-1102

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