NDC codes

FDA NDC Directory
Product NDC (as listed)51316-914Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0914Add 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
51316-914-03513160914031 BOTTLE in 1 CARTON (51316-914-03) / 120 mL in 1 BOTTLEMarketed from May 1, 2025

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
CVS
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210149
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 51316-914_e6233c7c-0364-4c07-906a-3f6ca7cac1a6SPL ID e6233c7c-0364-4c07-906a-3f6ca7cac1a6SPL set ID 2cf2a4de-29d3-8af5-e063-6294a90a9ceeRxCUI 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

N451316091403 followed by a unit qualifier and the quantity

Package 51316-0914-03. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 210149

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

FDA NDC Directory listings under ANDA 210149
ProductStrengthForm · routeLabelerProduct NDC
Childrens Ibuprofen bubblegumibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralGuardian Drug Company53041-572
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralGuardian Drug Company53041-634
Childrens Ibuprofen fruitibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralGuardian Drug Company53041-632
Childrens Ibuprofen 572ibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralFamily Dollar Services, Inc.55319-929
Childrens Ibuprofen blue raspberryibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralGuardian Drug Company53041-638
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralHarris Teeter, LLC69256-634
Childrens Ibuprofen grapeibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralGuardian Drug Company53041-639
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralChain Drug Marketing Association Inc.83324-014
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralChain Drug Marketing Association Inc.83324-012
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralChain Drug Marketing Association Inc.83324-013
Childrens Ibuprofen Bubblegum Dye FreeibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralCVS51316-932
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralFamily Dollar Services, Inc.55319-114
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralDiscount Drug Mart, Inc53943-682

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