Over-the-counter drug · ANDA

Ibuprofen NDC 55910-197

Ibuprofen 200 mg/1 · Capsule, Liquid filled · Oral · Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

NDC codes

FDA NDC Directory
Product NDC (as listed)55910-197Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55910-0197Add 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
55910-197-12559100197121 BOTTLE, PLASTIC in 1 BOX (55910-197-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTICMarketed from Apr 30, 2021
55910-197-20559100197201 BOTTLE, PLASTIC in 1 BOX (55910-197-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTICMarketed from Apr 30, 2021
55910-197-40559100197401 BOTTLE, PLASTIC in 1 BOX (55910-197-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTICMarketed from Apr 30, 2021
55910-197-80559100197801 BOTTLE, PLASTIC in 1 BOX (55910-197-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTICMarketed from Apr 30, 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 — 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 078682
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 55910-197_9bcf0bae-dc0d-454f-8d77-6a80a3c55bb0SPL ID 9bcf0bae-dc0d-454f-8d77-6a80a3c55bb0SPL set ID 7f510feb-023c-4974-af6d-3e7a30cef362RxCUI 310964UNII WK2XYI10QMUPC 0359726272803

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

N455910019712 followed by a unit qualifier and the quantity

Package 55910-0197-12. 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 muscular 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 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
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralRite Aid Corporation11822-3307
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.83324-210
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralChain Drug Marketing Association, Inc.83324-207
Motrin IB MigraineibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralKenvue Brands LLC50580-120
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralKROGER COMPANY30142-053
Dolex FlexibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralPharmadel LLC55758-014
Ibuprofen, Solubilized 24/7 Life by 7-Elevenibuprofen capsule, liquid filledIbuprofen 200 mg/1Capsule, Liquid filledOralLil' Drug Store products, Inc.66715-5646
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralTOP CARE (Topco Associates LLC)36800-570
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralDOLGENCORP INC55910-518
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralCardinal Health (Leader) 7000070000-0571
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralCostco Wholesale63981-598
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralWALGREEN COMPANY0363-0221
dye-free pain reliefibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-513
Ibuprofen MigraineibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralCVS Pharmacy69842-892
Motrin IBibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralKenvue Brands LLC50580-409
Ibuprofen Mini Dye FreeibuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralCVS Pharmacy51316-890
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralGobrands, Inc. (Goodnow)82501-1010

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