Over-the-counter drug · ANDA

Childrens Ibuprofen (Ibuprofen) NDC 68094-503

Ibuprofen 100 mg/5mL · Suspension · Oral · Precision Dose Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68094-503Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68094-0503Add 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
68094-503-61680940503616809405036110 TRAY in 1 CASE (68094-503-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-503-59)Marketed from Sep 14, 2006
68094-503-6268094050362680940503623 TRAY in 1 CASE (68094-503-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-503-59)Marketed from Sep 14, 2006

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)
Childrens Ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 100 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Precision Dose Inc.NDC labeler code 68094
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074937
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 68094-503_569c23f2-55ee-4921-80ca-9362c8ce58b6SPL ID 569c23f2-55ee-4921-80ca-9362c8ce58b6SPL set ID 59b881f9-1830-4bce-99d2-9770c9b2575fRxCUI 197803UNII 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

N468094050361 followed by a unit qualifier and the quantity

Package 68094-0503-61. 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 the common cold, flu, sore throat, headache and toothache reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68094-503

What is NDC 68094-503?
68094-503 is the product NDC for Childrens Ibuprofen (ibuprofen), Ibuprofen 100 mg/5mL suspension, listed with the FDA by Precision Dose Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Childrens Ibuprofen (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Precision Dose Inc., NDC labeler code 68094. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Childrens Ibuprofen?
54 other product NDCs are listed under this name. See all Childrens 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 Childrens Ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-39272288-0392-34
Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralAmazon.com Services LLC72288-32072288-0320-62
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAdvagen Pharma Ltd.72888-47972888-0479-01
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralPreferred Pharmaceuticals Inc.68788-403168788-4031-01
childrens ibuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralSafeway21130-79021130-0790-62
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralSafeway21130-50621130-0506-26
Childrens IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralMeijer, Inc.79481-041979481-0419-00
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralSafeway21130-51021130-0510-26
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralBetter Living Brands, LLC21130-21621130-0216-20
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralDiscount Drug Mart, Inc53943-68253943-0682-03

All 55 Childrens Ibuprofen NDCs

Other NDCs under ANDA 074937

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

FDA NDC Directory listings under ANDA 074937
ProductStrengthForm · routeLabelerProduct NDC
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-166
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-660
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-685
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-897
care one ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerican Sales Company41520-897
care one ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerican Sales Company41520-166
Care One ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerican Sales Company41520-685
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralRite Aid Corporation11822-0166
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralRite Aid Corporation11822-1685
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralSafeway21130-506
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralSafeway21130-510
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralH E B37808-200
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralMeijer Distribution Inc41250-419
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralMeijer Distribution Inc41250-685
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralHyVee Inc42507-685
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralPadagis Israel Pharmaceuticals Ltd45802-133
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralPadagis Israel Pharmaceuticals Ltd45802-140
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCardinal Health 107, LLC55154-1577
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCVS Pharmacy59779-971
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralNuCare Pharmaceuticals, Inc.68071-5290

Showing 20 of 39.

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