Prescription drug · ANDA

Ibuprofen NDC 72789-200

Ibuprofen 800 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)72789-200Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72789-0200Add 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
72789-200-107278902001010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-10)Marketed from Sep 28, 2021
72789-200-127278902001212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-12)Marketed from Oct 11, 2021
72789-200-157278902001515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-15)Marketed from Sep 21, 2021
72789-200-207278902002020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-20)Marketed from Sep 28, 2021
72789-200-217278902002121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-21)Marketed from Sep 28, 2021
72789-200-307278902003030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-30)Marketed from Aug 23, 2021
72789-200-407278902004040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-40)Marketed from Sep 28, 2021
72789-200-607278902006060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-60)Marketed from Aug 23, 2021
72789-200-907278902009090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-90)Marketed from Aug 23, 2021
72789-200-9372789020093180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-93)Marketed from Sep 28, 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)
Ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 800 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078329
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 72789-200_3417f658-e09c-4667-e063-6394a90a7228SPL ID 3417f658-e09c-4667-e063-6394a90a7228SPL set ID 689dbbe8-4f85-48fe-8efc-fda81b60d37fRxCUI 197807UNII WK2XYI10QMUPC 0372789200200

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

N472789020010 followed by a unit qualifier and the quantity

Package 72789-0200-10. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078329

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

FDA NDC Directory listings under ANDA 078329
ProductStrengthForm · routeLabelerProduct NDC
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralDirect_Rx72189-643
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3108
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4741
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5228
IbuprofenIbuprofen 800 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0537
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-808
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-807
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-809
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-629
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-890
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-895
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralProficient Rx LP71205-464
IbuprofenIbuprofen 800 mg/1TabletOralSOLA Pharmaceuticals, LLC70512-780
IbuprofenIbuprofen 800 mg/1TabletOralAsclemed USA, Inc.76420-415
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4845
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8531
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4887
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1206
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8309
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1207

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