Over-the-counter drug · ANDA

Ibuprofen 200 mg (Ibuprofen) NDC 69168-368

Ibuprofen 200 mg/1 · Capsule, Liquid filled · Oral · Allegiant Health

NDC codes

FDA NDC Directory
Product NDC (as listed)69168-368Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0368Add 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
69168-368-0769168036807691680368071 BOTTLE in 1 CARTON (69168-368-07) / 10 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Dec 22, 2014
69168-368-3069168036830691680368301 BOTTLE in 1 CARTON (69168-368-30) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Dec 22, 2014

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 200 mg
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
Allegiant HealthNDC labeler code 69168
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079205
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 69168-368_2384fd3b-de52-46c9-bea9-4d8a0342fe59SPL ID 2384fd3b-de52-46c9-bea9-4d8a0342fe59SPL set ID 8ba06ba0-bfe9-4626-af65-dae4d6a3a2adRxCUI 310964UNII WK2XYI10QM

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

N469168036807 followed by a unit qualifier and the quantity

Package 69168-0368-07. 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)

Use(s) temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69168-368

What is NDC 69168-368?
69168-368 is the product NDC for Ibuprofen 200 mg (ibuprofen), Ibuprofen 200 mg/1 capsule, liquid filled, listed with the FDA by Allegiant Health. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ibuprofen 200 mg (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Allegiant Health, NDC labeler code 69168. 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 200 mg?
6 other product NDCs are listed under this name. See all Ibuprofen 200 mg 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 200 mg NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ibuprofen 200 MgIbuprofen 200 mg/1Tablet, CoatedOralFarmacias De Similares TX LLC85786-10785786-0107-30
Ibuprofen 200 mgibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralR J General Corporation70264-04470264-0044-01
Ibuprofen 200 mgibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralR J General Corporation70264-04370264-0043-01
Ibuprofen 200 mgibuprofenIbuprofen 200 mg/1Tablet, CoatedOralR J General Corporation70264-04170264-0041-01
Ibuprofen 200 mgibuprofenIbuprofen 200 mg/1Tablet, CoatedOralR J General Corporation70264-04270264-0042-01
Ibuprofen 200 MgibuprofenIbuprofen 200 mg/1TabletOralBasic Drugs, Inc.0761-090800761-0908-04

Other NDCs under ANDA 079205

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

FDA NDC Directory listings under ANDA 079205
ProductStrengthForm · routeLabelerProduct NDC
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralWALGREENS0363-1610
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralWALGREENS0363-8574
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralTARGET CORPORATION11673-992
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralBETTER LIVING BRANDS, LLC21130-070
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralBETTER LIVING BRANDS, LLC21130-361
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralMARKSANS PHARMA LIMITED25000-062
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralMARKSANS PHARMA LIMITED25000-133
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralUnited Natural Foods, Inc. dba UNFI41163-185
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralKroger Company41226-610
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralKROGER COMPANY41226-700
Ibuprofenibuprofen capsules 200 mgIbuprofen 200 mg/1Capsule, Liquid filledOralTIME CAP LABORATORIES, INC.49483-133
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralTIME CAP LABORATORIES, INC49483-610
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralTIME CAP LABORATORIES, INC.49483-700
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralGOODSENSE50804-185
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralDOLGENCORP, INC.55910-399
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralAMERIFOODS TRADING COMPANY61504-185
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralWinco Foods, LLC67091-185
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralSPIRIT PHARMACEUTICALS,LLC68210-0200
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralBJWC (Berkley & Jensen / BJ's)68391-610
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralMARC GLASSMAN, INC.68998-185

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