NDC codes

FDA NDC Directory
Product NDC (as listed)55319-929Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55319-0929Add 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
55319-929-0355319092903553190929031 BOTTLE in 1 CARTON (55319-929-03) / 120 mL in 1 BOTTLEMarketed from Apr 18, 2024

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 572
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 100 mg/5mL
Dosage form
Suspension/ drops
Route
Oral
Labeler
Family Dollar Services, Inc.NDC labeler code 55319
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 55319-929_3da7e78b-2397-42c5-8a9e-1dc9ae0afea4SPL ID 3da7e78b-2397-42c5-8a9e-1dc9ae0afea4SPL set ID 1a2182df-4339-442d-9c61-98c8b01e36faRxCUI 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

N455319092903 followed by a unit qualifier and the quantity

Package 55319-0929-03. 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)

USE(S) 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 55319-929

What is NDC 55319-929?
55319-929 is the product NDC for Childrens Ibuprofen 572 (ibuprofen), Ibuprofen 100 mg/5mL suspension/ drops, listed with the FDA by Family Dollar Services, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Childrens Ibuprofen 572 (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Family Dollar Services, Inc., NDC labeler code 55319. 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 572?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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 IbuprofenibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralGuardian Drug Company53041-634
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralDiscount Drug Mart, Inc53943-682
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralFamily Dollar Services, Inc.55319-114
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralHarris Teeter, LLC69256-634
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 IbuprofenibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralChain Drug Marketing Association Inc.83324-014
Childrens Ibuprofen blue raspberryibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralGuardian Drug Company53041-638
Childrens Ibuprofen bubblegumibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralGuardian Drug Company53041-572
Childrens Ibuprofen Bubblegum Dye FreeibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralCVS51316-932
Childrens Ibuprofen fruitibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralGuardian Drug Company53041-632
Childrens Ibuprofen grapeibuprofenIbuprofen 100 mg/5mLSuspension/ dropsOralGuardian Drug Company53041-639
Dye Free Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCVS51316-914

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