Over-the-counter drug · ANDA

Ibuprofen NDC 55319-252

Ibuprofen 200 mg/1 · Tablet, Coated · Oral · Family Dollar (FAMILY WELLNESS)

NDC codes

FDA NDC Directory
Product NDC (as listed)55319-252Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55319-0252Add 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
55319-252-0555319025205500 TABLET, COATED in 1 BOTTLE (55319-252-05)Marketed from Sep 15, 2023
55319-252-10553190252101 BOTTLE, PLASTIC in 1 BOX (55319-252-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Sep 15, 2023
55319-252-24553190252241 BOTTLE, PLASTIC in 1 BOX (55319-252-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Sep 15, 2023
55319-252-25553190252251 BOTTLE, PLASTIC in 1 BOX (55319-252-25) / 250 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Sep 15, 2023
55319-252-50553190252501 BOTTLE, PLASTIC in 1 BOX (55319-252-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Sep 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)
Ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/1
Dosage form
Tablet, Coated
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079129
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 55319-252_507df8d5-42bb-4c21-b28e-4b40e48879d0SPL ID 507df8d5-42bb-4c21-b28e-4b40e48879d0SPL set ID da16b1a9-0db2-4f2f-bc85-05ea5ab26e1cRxCUI 310965UNII WK2XYI10QMUPC 0032251935190

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

N455319025205 followed by a unit qualifier and the quantity

Package 55319-0252-05. 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 muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps 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 079129

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

FDA NDC Directory listings under ANDA 079129
ProductStrengthForm · routeLabelerProduct NDC
GoodMeds Ibuprofen 200mgibuprofen 200mgIbuprofen 200 mg/1TabletOralCabinet Health P.B.C.82725-4029
CVS IbuprofenibuprofenIbuprofen 200 mg/1TabletOralCVS Pharmacy51316-187
Ibuprofen, Circle K, 50ctibuprofenIbuprofen 200 mg/1Tablet, CoatedOralLil' Drug Store Products, Inc.66715-5607
IbuprofenIbuprofen 200 mg/1TabletOralPioneer Life Sciences, LLC72090-070
RIGHT REMEDIES Ibuprofen 200 MGibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralStrive Pharmaceuticals Inc.70692-179
Ibuprofen, Caseys, 50ctibuprofenIbuprofen 200 mg/1Tablet, CoatedOralLil' Drug Store Products, Inc.66715-6407
Ibuprofen Fast relief medicine for painibuprofen 200 mgIbuprofen 200 mg/1TabletOralAllegiant Health69168-335
Ibuprofen, Lil Drug Store, 24ctibuprofenIbuprofen 200 mg/1Tablet, CoatedOralLil' Drug Store Products, Inc.66715-6739
Ibuprofen, Lil Drug Store, 50ctibuprofenIbuprofen 200 mg/1Tablet, CoatedOralLil' Drug Store Products, Inc.66715-6720
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralFamily Dollar (FAMILY WELLNESS)55319-137
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralFamily Dollar (FAMILY WELLNESS)55319-136
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralP & L Development, LLC59726-003
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralP & L Development, LLC59726-139
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralStrategic Sourcing Services, LLC70677-1244
IbuprofenIbuprofen 200 mg/1TabletOralNUVICARE LLC84324-038
Flex-PrinibuprofenIbuprofen 200 mg/1TabletOralProvision Medical Products69103-2525
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralAAA Pharmaceutical, Inc.57344-109
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralAAA Pharmaceutical, Inc.57344-110
IBUPROFEN Immediate ReleaseibuprofenIbuprofen 200 mg/1Tablet, CoatedOralStrides Pharma Inc59556-857
IBUPROFEN Immediate ReleaseibuprofenIbuprofen 200 mg/1Tablet, CoatedOralStrides Pharma Inc59556-858

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