Over-the-counter drug · ANDA

Valumeds Ibuprofen (ibuprofen) NDC 68210-0800

Ibuprofen 200 mg/1 · Tablet, Film coated · Oral · SPIRIT PHARMACEUTICALS LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)68210-0800Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68210-0800Add 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
68210-0800-168210080001100 TABLET, FILM COATED in 1 BOTTLE (68210-0800-1)Marketed from May 19, 2017
68210-0800-4682100800041 BOTTLE in 1 CARTON (68210-0800-4) / 40 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 11, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Valumeds Ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091239
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 68210-0800_28ed10e2-9113-a062-e063-6394a90a0ba3SPL ID 28ed10e2-9113-a062-e063-6394a90a0ba3SPL set ID a6d4ceb0-2b79-496a-aa1e-27edd507ced0RxCUI 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

N468210080001 followed by a unit qualifier and the quantity

Package 68210-0800-01. 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: 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)

Other NDCs under ANDA 091239

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

FDA NDC Directory listings under ANDA 091239
ProductStrengthForm · routeLabelerProduct NDC
IbuprofenIbuprofen 200 mg/1TabletOralBETTER LIVING BRANDS, LLC21130-006
AeroTab Ibuprofenibuprofen tabletIbuprofen 200 mg/1000mgTablet, CoatedOralAero Healthcare55305-133
IbuprofenIbuprofen 200 mg/1TabletOralMARKSANS PHARMA LIMITED25000-114
IbuprofenIbuprofen 200 mg/1TabletOralMARKSANS PHARMA LIMITED25000-117
Ibuprofen CaibuprofenIbuprofen 200 mg/1Tablet, CoatedOralTARGET CORPORATION11673-990
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralTARGET CORPORATION11673-991
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralRITE AID CORPORATION11822-7891
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralRITE AID CORPORATION11822-7892
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralTIME CAP LABORATORIES,INC49483-114
IbuprofenIbuprofen 200 mg/1TabletOralBETTER LIVING BRANDS, LLC21130-261
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralGrocery Outlet, Inc.85828-601
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralKroger Company41226-600
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralTIME CAP LABORATORIES,INC49483-601
IbuprofenibupfrofenIbuprofen 200 mg/1Tablet, Film coatedOralTIME CAP LABORATORIES,INC49483-600
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralSAM'S WEST INC68196-601
IbuprofenIbuprofen 200 mg/1TabletOralWALGREENS0363-9600
ibuprofenIbuprofen 200 mg/1Tablet, CoatedOralDOLGENCORP INC55910-901
IbuprofenIbuprofen 200 mg/1TabletOralWALGREENS0363-9601

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