Over-the-counter drug · ANDA

Ibuprofen NDC 36800-440

Ibuprofen 200 mg/1 · Capsule, Liquid filled · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-440Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0440Add 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
36800-440-2936800044029180 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-440-29)Marketed from May 30, 2018
36800-440-80368000440802 BOTTLE in 1 PACKAGE (36800-440-80) / 180 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from May 30, 2018

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)
Ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206568
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 36800-440_a15041f7-99a8-4b99-8bbc-727bb7554d3dSPL ID a15041f7-99a8-4b99-8bbc-727bb7554d3dSPL set ID 4aef9935-2e36-4779-a8a8-5288060573afRxCUI 310964UNII 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

N436800044029 followed by a unit qualifier and the quantity

Package 36800-0440-29. 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: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206568

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

FDA NDC Directory listings under ANDA 206568
ProductStrengthForm · routeLabelerProduct NDC
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralCVS Pharmacy69842-745
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralPuraCap Pharmaceutical LLC51013-103
Ibuprofen minisibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-953
Ibuprofen minisibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralThe Kroger Co.30142-743
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralThe Kroger Co.30142-745
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralPuraCap Pharmaceutical LLC51013-410
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralPuraCap Pharmaceutical LLC51013-405
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralPuraCap Pharmaceutical LLC51013-421
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralPuraCap Pharmaceutical LLC51013-422
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralPURACAP PHARMACEUTICAL LLC51013-429
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralAAFES/Your Military Exchanges55301-745
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralRugby Laboratories, Inc.0536-1147
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralCare One (American Sales Company)41520-745
Ibuprofen MinisibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralFamily Dollar (FAMILY WELLNESS)55319-971
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralCare One (Retail Business Services, LLC.)72476-745
Ibuprofen minisibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralCare One (Retail Business Services, LLC.)72476-843
Ibuprofen minisibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralStrategic Sourcing Services LLC70677-1113
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralStrategic Sourcing Services LLC70677-1114
Ibuprofen minisibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralWR Group, Inc.69607-8438
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralChain Drug Consortium, LLC68016-813

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