Over-the-counter drug · ANDA

Ibuprofen NDC 68998-109

Ibuprofen 200 mg/1 · Tablet, Coated · Oral · Marc Glassman, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68998-109Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68998-0109Add 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
68998-109-0368998010903689980109031 BOTTLE, PLASTIC in 1 CARTON (68998-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Jun 1, 2009
68998-109-056899801090568998010905500 TABLET, COATED in 1 BOTTLE, PLASTIC (68998-109-05)Marketed from Jun 1, 2009
68998-109-086899801090868998010908250 TABLET, COATED in 1 BOTTLE, PLASTIC (68998-109-08)Marketed from Aug 1, 2012
68998-109-1068998010910689980109102 BOTTLE, PLASTIC in 1 CARTON (68998-109-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Sep 1, 2015

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, Coated
Route
Oral
Labeler
Marc Glassman, Inc.NDC labeler code 68998
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 68998-109_374dc1c0-4246-b272-e063-6394a90a5a6bSPL ID 374dc1c0-4246-b272-e063-6394a90a5a6bSPL set ID 47434f23-5ac9-4cb4-a963-7c8bf9e06361RxCUI 310965UNII WK2XYI10QMUPC 0099581910204

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

N468998010903 followed by a unit qualifier and the quantity

Package 68998-0109-03. 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 muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68998-109

What is NDC 68998-109?
68998-109 is the product NDC for Ibuprofen, Ibuprofen 200 mg/1 tablet, coated, listed with the FDA by Marc Glassman, Inc.. It has 4 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?
Marc Glassman, Inc., NDC labeler code 68998. 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 600 mg/1Tablet, Film coatedOralMedcore LLC82461-72482461-0724-90
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralMedcore LLC82461-72582461-0725-90
IbuprofenIbuprofen 200 mg/1TabletOralAurohealth LLC58602-91358602-0913-1758602-0913-40
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73767877-0737-0167877-0737-0567877-0737-33+1 more
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73867877-0738-0167877-0738-0567877-0738-30+3 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 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.68998-110
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
Ibuwin ForteibuprofenIbuprofen 200 mg/1TabletOralOPMX LLC69729-157

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