Over-the-counter drug · ANDA

Dye-Free Ibuprofen (Ibuprofen) NDC 63868-805

Ibuprofen 200 mg/1201 · Capsule, Liquid filled · Oral · CHAIN DRUG MARKETING ASSOCIATION INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)63868-805Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63868-0805Add 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
63868-805-4063868080540638680805401 BOTTLE in 1 CARTON (63868-805-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Nov 16, 2021

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 Ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/1201
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC.NDC labeler code 63868
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078682
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 63868-805_f0d274bd-b6b5-74c9-e053-2995a90a6f72SPL ID f0d274bd-b6b5-74c9-e053-2995a90a6f72SPL set ID d0eff659-6445-a56a-e053-2995a90a72e9RxCUI 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

N463868080540 followed by a unit qualifier and the quantity

Package 63868-0805-40. 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)

About NDC 63868-805

What is NDC 63868-805?
63868-805 is the product NDC for Dye-Free Ibuprofen (ibuprofen), Ibuprofen 200 mg/1201 capsule, liquid filled, listed with the FDA by CHAIN DRUG MARKETING ASSOCIATION INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dye-Free Ibuprofen (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
CHAIN DRUG MARKETING ASSOCIATION INC., NDC labeler code 63868. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dye-Free Ibuprofen?
4 other product NDCs are listed under this name. See all Dye-Free 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 Dye-Free Ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Dye-Free IbuprofenibuprofenIbuprofen 200 mg/1201Capsule, Liquid filledOralRITE AID CORPORATION11822-187911822-1879-01
Dye Free IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWalgreen Company0363-043800363-0438-3200363-0438-9800363-0438-99
Dye Free IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWalgreen Company0363-438100363-4381-12
Dye Free IbuprofenibuprofenIbuprofen 200 mg/1TabletOralBreeden Brothers, LLC70729-00270729-0002-2470729-0002-50

Other NDCs under ANDA 078682

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

FDA NDC Directory listings under ANDA 078682
ProductStrengthForm · routeLabelerProduct NDC
Migraine ReliefibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralWALGREENS0363-0240
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralL.N.K. International, Inc.50844-754
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralChain Drug Marketing Association, Inc.63868-470
Dye-Free IbuprofenibuprofenIbuprofen 200 mg/1201Capsule, Liquid filledOralRITE AID CORPORATION11822-1879
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-212
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-239
Dye-Free Ibuprofen 200ibuprofenIbuprofen 200 mg/1201Capsule, Liquid filledOralWALGREEN COMPANY0363-0103
pain reliefibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-260
pain reliefibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-262
Migraine ReliefibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-263
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralWal-Mart Stores, Inc.49035-381
Ibuprofenibuprofen capsuleIbuprofen 200 mg/1Capsule, Liquid filledOralPUBLIX SUPER MARKETS INC56062-560
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralGobrands, Inc. (Goodnow)82501-1010
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralChain Drug Marketing Association, Inc.83324-206
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralCHAIN DRUG MARKETING ASSOCIATION INC.83324-203
Ibuprofen mini dye freeibuprofenIbuprofen 200 mg/1201Capsule, Liquid filledOralCHAIN DRUG MARKETING ASSOCIATION INC.83324-204
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralChain Drug Marketing Association, Inc.83324-207
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralDISCOUNT DRUG MART, INC.53943-212
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralCHAIN DRUG MARKETING ASSOCIATION INC.83324-210
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralKROGER COMPANY30142-053

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