Over-the-counter drug · ANDA

Ibuprofen Oral NDC 70677-0153

Ibuprofen 100 mg/5mL · Suspension · Oral · Strategic Sourcing Services

NDC codes

FDA NDC Directory
Product NDC (as listed)70677-0153Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70677-0153Add 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
70677-0153-170677015301706770153011 BOTTLE in 1 CARTON (70677-0153-1) / 118 mL in 1 BOTTLEMarketed from Aug 1, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Ibuprofen Oral
Generic name (nonproprietary)
ibuprofen oral
Active ingredients
Ibuprofen — 100 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Strategic Sourcing ServicesNDC labeler code 70677
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210602
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 70677-0153_e5e79c54-bf94-3d7d-e053-2995a90a3812SPL ID e5e79c54-bf94-3d7d-e053-2995a90a3812SPL set ID a3062142-db0e-4758-a762-2b2bb05670b1RxCUI 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

N470677015301 followed by a unit qualifier and the quantity

Package 70677-0153-01. 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 70677-0153

What is NDC 70677-0153?
70677-0153 is the product NDC for Ibuprofen Oral, Ibuprofen 100 mg/5mL suspension, listed with the FDA by Strategic Sourcing Services. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ibuprofen Oral.
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Strategic Sourcing Services, NDC labeler code 70677. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ibuprofen Oral?
21 other product NDCs are listed under this name. See all Ibuprofen Oral 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 Ibuprofen Oral NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack72162-190972162-1909-02
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralStrategic Sourcing Services70677-111570677-1115-0170677-1115-02
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralStrategic Sourcing Services70677-111670677-1116-01
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralStrategic Sourcing Services70677-111770677-1117-01
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralStrategic Sourcing Services70677-111870677-1118-01
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralStrategic Sourcing Services70677-015170677-0151-01
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralStrategic Sourcing Services70677-015270677-0152-01
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-885163629-8851-01
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-885263629-8852-01
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-885363629-8853-01

All 22 Ibuprofen Oral NDCs

Other NDCs under ANDA 210602

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

FDA NDC Directory listings under ANDA 210602
ProductStrengthForm · routeLabelerProduct NDC
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerican Health Packaging60687-743
Childrens Ibuprofen GrapeibuprofenIbuprofen 100 mg/5mLSuspensionOralAptaPharma Inc.76281-126
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralDEMOULAS SUPERMARKETS INC.53942-119
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralDiscount Drug Mart53943-119
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralChain Drug Marketing Association, Inc.63868-796
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralMarc Glassman, Inc.68998-320
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralAptaPharma Inc.76281-119
Childrens Ibuprofen Oral Suspension Dye freeibuprofenIbuprofen 100 mg/5mLSuspensionOralAptaPharma Inc.76281-128
Childrens Ibuprofen Oral Suspension Dye FreeibuprofenIbuprofen 100 mg/5mLSuspensionOralFSA Store Inc. (Caring Mill)81522-311
Childrens Ibuprofen Oral Suspension Original Berry FlavoribuprofenIbuprofen 100 mg/5mLSuspensionOralPuro Pharma Inc.83474-002
Childrens Ibuprofen Oral Suspension, Bubble GumibuprofenIbuprofen 100 mg/5mLSuspensionOralBest Choice63941-127
Childrens Ibuprofen Oral Suspension, Dye FreeibuprofenIbuprofen 100 mg/5mLSuspensionOralBest Choice63941-128
Dolex ChildrenibuprofenIbuprofen 100 mg/100mLLiquidOralPharmadel LLC55758-304
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralA-S Medication Solutions50090-4129
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-8540
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-8851
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-8852
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-8853
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralNuCare Pharmaceuticals,Inc.68071-1628
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralCamber Consumer Care Inc69230-308

Showing 20 of 37.

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