Over-the-counter drug · ANDA

Childrens Ibuprofen (Ibuprofen) NDC 52412-911

Ibuprofen 100 mg/5mL · Suspension · Oral · Randob Labs., Ltd.

NDC codes

FDA NDC Directory
Product NDC (as listed)52412-911Labeler and product segments. Claims need a package NDC.
Product NDC at billing width52412-0911Add 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
52412-911-0452412091104524120911041 BOTTLE in 1 CARTON (52412-911-04) / 120 mL in 1 BOTTLEMarketed from Jul 15, 2023

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
Randob Labs., Ltd.NDC labeler code 52412
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209179
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 52412-911_d97115c6-f191-4faa-8e74-3e8817e4a48fSPL ID d97115c6-f191-4faa-8e74-3e8817e4a48fSPL set ID 50d6bf9d-ae37-4af3-bfeb-cc0abf8cb094RxCUI 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

N452412091104 followed by a unit qualifier and the quantity

Package 52412-0911-04. 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 52412-911

What is NDC 52412-911?
52412-911 is the product NDC for Childrens Ibuprofen (ibuprofen), Ibuprofen 100 mg/5mL suspension, listed with the FDA by Randob Labs., Ltd.. It has 1 package NDC, 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?
Randob Labs., Ltd., NDC labeler code 52412. 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 209179

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

FDA NDC Directory listings under ANDA 209179
ProductStrengthForm · routeLabelerProduct NDC
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralKROGER COMPANY30142-281
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAurohealth LLC58602-002
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAurohealth LLC58602-003
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAurohealth LLC58602-008
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralBluePoint Laboratories68001-521
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralBetter Living Brands, LLC21130-216
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOral7-Eleven10202-150
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralWALGREEN CO.0363-8901
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOral7-Eleven10202-711
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralChalkboard Health79395-003
Childrens FLANAX ORALibuprofenIbuprofen 100 mg/5mLSuspensionOralBelmora LLC27854-777

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