NDC codes

FDA NDC Directory
Product NDC (as listed)68016-634Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68016-0634Add 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
68016-634-00680160634001000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-00)Marketed from May 24, 1988
68016-634-0568016063405500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-05)Marketed from May 24, 1988
68016-634-10680160634101 BOTTLE, PLASTIC in 1 CARTON (68016-634-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from May 24, 1988
68016-634-24680160634241 BOTTLE, PLASTIC in 1 CARTON (68016-634-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from May 24, 1988
68016-634-2568016063425250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-25)Marketed from May 24, 1988
68016-634-50680160634501 BOTTLE, PLASTIC in 1 CARTON (68016-634-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from May 24, 1988

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 — 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 075010
Marketing start
Marketing end
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 68016-634_4ce3d600-a2ba-4e98-b513-e6e5884ae9a2SPL ID 4ce3d600-a2ba-4e98-b513-e6e5884ae9a2SPL set ID 6c593a9c-680e-4645-8e8f-d8d044c92ca1RxCUI 310965UNII WK2XYI10QMUPC 0840986031571

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

N468016063400 followed by a unit qualifier and the quantity

Package 68016-0634-00. 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 075010

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

FDA NDC Directory listings under ANDA 075010
ProductStrengthForm · routeLabelerProduct NDC
Unishield IbuprofenibuprofenIbuprofen 200 mg/1Tablet, CoatedOralUnishield49314-0993
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralCVS Pharmacy59779-291
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralH E B37808-921
Physicians Care Ibuprofenibuprofen 200mgIbuprofen 200 mg/1Tablet, CoatedOralAcme United Corporation0924-0075
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralH E B37808-922
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralCHAIN DRUG MARKETING ASSOCIATION INC63868-979
Circle K IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLil Drug Store Products, Inc66715-5539
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralGeri-Care Pharmaceutical Corp57896-941
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralSalado Sales, Inc.57243-291
Pain Relief IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralRite Aid Corporation11822-0292
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralRite Aid Corporation11822-0291
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralCOSTCO WHOLESALE CORPORATION63981-291
Ibuprofen, Caseys 4goodibuprofen tablet, film-coatedIbuprofen 200 mg/1Tablet, Film coatedOralLil' Drug Store Products, Inc.66715-6339
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralL.N.K. International, Inc.50844-257
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralINGLES MARKETS, INC.62936-0941
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralL.N.K. International, Inc.50844-291
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralL.N.K. International, Inc.50844-292
Uline IbuprofenibuprofenIbuprofen 200 mg/1Tablet, CoatedOralUline69790-609
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralChain Drug Marketing Association, Inc.83324-056
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralChain Drug Marketing Association, Inc.83324-059

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