Over-the-counter drug · ANDA

Dye Free Childrens Ibuprofen (Ibuprofen) NDC 68094-600

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

NDC codes

FDA NDC Directory
Product NDC (as listed)68094-600Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68094-0600Add 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
68094-600-61680940600616809406006110 TRAY in 1 CASE (68094-600-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-600-59)Marketed from Aug 26, 2015
68094-600-6268094060062680940600623 TRAY in 1 CASE (68094-600-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-600-59)Marketed from Aug 26, 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)
Dye Free 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 68094-600_df2a68e8-8400-4e49-ba13-bd66284bec52SPL ID df2a68e8-8400-4e49-ba13-bd66284bec52SPL set ID eccee4c6-aa94-468a-aebd-265d7a9efb6dRxCUI 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

N468094060061 followed by a unit qualifier and the quantity

Package 68094-0600-61. 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 68094-600

What is NDC 68094-600?
68094-600 is the product NDC for Dye Free 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?
Dye Free 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 Dye Free Childrens Ibuprofen?
1 other product NDC are listed under this name. See all Dye Free 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 Dye Free Childrens Ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Dye Free Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCVS51316-91451316-0914-03

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

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