Over-the-counter drug · ANDA

Ibuprofen 200mg (Ibuprofen) NDC 69168-381

Ibuprofen 200 mg/1 · Tablet · Oral · Allegiant Health

NDC codes

FDA NDC Directory
Product NDC (as listed)69168-381Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0381Add 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
69168-381-0169168038101691680381011 BOTTLE in 1 CARTON (69168-381-01) / 100 TABLET in 1 BOTTLEMarketed from Nov 16, 2021
69168-381-036916803810369168038103250 TABLET in 1 BOTTLE (69168-381-03)Marketed from Nov 16, 2021
69168-381-056916803810569168038105500 TABLET in 1 BOTTLE (69168-381-05)Marketed from Nov 16, 2021
69168-381-3069168038130691680381301 BOTTLE in 1 CARTON (69168-381-30) / 30 TABLET in 1 BOTTLEMarketed from Nov 16, 2021
69168-381-326916803813269168038132100 TABLET in 1 BOTTLE (69168-381-32)Marketed from May 18, 2022
69168-381-4069168038140691680381401 BOTTLE in 1 CARTON (69168-381-40) / 40 TABLET in 1 BOTTLEMarketed from Nov 16, 2021

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 200mg
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Allegiant HealthNDC labeler code 69168
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079174
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 69168-381_ccb176fa-b1be-4552-ab01-c8a0643e063cSPL ID ccb176fa-b1be-4552-ab01-c8a0643e063cSPL set ID f3f12b86-89dc-427e-a26f-728be6f73e7bRxCUI 310965UNII 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

N469168038101 followed by a unit qualifier and the quantity

Package 69168-0381-01. 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)

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 69168-381

What is NDC 69168-381?
69168-381 is the product NDC for Ibuprofen 200mg (ibuprofen), Ibuprofen 200 mg/1 tablet, listed with the FDA by Allegiant Health. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ibuprofen 200mg (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 200mg?
4 other product NDCs are listed under this name. See all Ibuprofen 200mg 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 200mg NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ibuprofen 200mgIbuprofen 200 mg/1TabletOralAllegiant Health69168-46769168-0467-0169168-0467-0369168-0467-05+2 more
Ibuprofen 200mgIbuprofen 200 mg/1Tablet, CoatedOralAthlete's Needs, Inc.53185-38153185-0381-01
Ibuprofen 200mgIbuprofen 200 mg/1TabletOralAllegiant Health69168-38269168-0382-30
Ibuprofen 200mgIbuprofen 200 mg/1Tablet, Film coatedOralAllegiant Health69168-39069168-0390-30

Other NDCs under ANDA 079174

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

FDA NDC Directory listings under ANDA 079174
ProductStrengthForm · routeLabelerProduct NDC
Dover AddaprinibuprofenIbuprofen 200 mg/1Tablet, CoatedOralUnifirst First Aid Corporation47682-714
IbuprofenIbuprofen 200 mg/1TabletOralBETTER LIVING BRANDS LLC.21130-396
Medique IprinibuprofenIbuprofen 200 mg/1Tablet, CoatedOralUnifirst First Aid Corporation47682-700
Medi-First Plus IbuprofenibuprofenIbuprofen 200 mg/1Tablet, CoatedOralUnifirst First Aid Corporation47682-709
Pain Relief - Ibuprofen 200 mgibuprofenIbuprofen 200 mg/1Tablet, CoatedOralHealth Pharma USA LLC71679-111
Green Guard Ibuprofen ReliefibuprofenIbuprofen 200 mg/1Tablet, CoatedOralUnifirst First Aid47682-710
Medi-First IbuprofenibuprofenIbuprofen 200 mg/1Tablet, CoatedOralUnifirst First Aid Corporation47682-718
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralMarc Glassman, Inc.68998-109
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralMarc Glassman, Inc.68998-110
IbuprofenIbuprofen 200 mg/1TabletOralGranules USA, Inc.69848-011
IbuprofenIbuprofen 200 mg/1TabletOralGranules USA, Inc.69848-012
Direct Safety IbuprofenibuprofenIbuprofen 200 mg/1Tablet, CoatedOralConney Safety Products, LLC61245-084
Lil Drug Store IbuprofenibuprofenIbuprofen 200 mg/1TabletOralLil Drug Store Products, Inc66715-6839
Medique at Home IprinibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralUnifirst First Aid Corporation47682-783
Fast Pain ReliefibuprofenIbuprofen 200 mg/1Tablet, CoatedOralHealthLife of USA LLC69517-111
Physicians Care Ibuprofenibuprofen 200mgIbuprofen 200 mg/1Tablet, Film coatedOralAcme United Corporation0924-0076
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralAMERIFOODS TRADING COMPANY61504-109
IbuprofenIbuprofen 200 mg/1TabletOralRETAIL BUSINESS SERVICES,LLC.72476-365
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralAMERIFOODS TRADING COMPANY61504-110
IbuprofenIbuprofen 200 mg/1TabletOralRetail Business Services, LLC72476-366

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