Over-the-counter drug · ANDA

Physicians Care Ibuprofen (Ibuprofen 200mg) NDC 0924-0075

Ibuprofen 200 mg/1 · Tablet, Coated · Oral · Acme United Corporation

NDC codes

FDA NDC Directory
Product NDC (as listed)0924-0075Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00924-0075Add 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
0924-0075-0000924007500009240075002 TABLET, COATED in 1 PACKET (0924-0075-00)Marketed from Feb 1, 2016
0924-0075-01009240075010092400750150 PACKET in 1 CARTON (0924-0075-01) / 2 TABLET, COATED in 1 PACKET (0924-0075-00)Marketed from Feb 1, 2016
0924-0075-020092400750200924007502125 PACKET in 1 CARTON (0924-0075-02) / 2 TABLET, COATED in 1 PACKETMarketed from Feb 1, 2016
0924-0075-03009240075030092400750310 PACKET in 1 CARTON (0924-0075-03) / 2 TABLET, COATED in 1 PACKET (0924-0075-00)Marketed from Feb 1, 2016
0924-0075-0400924007504009240075046 PACKET in 1 CARTON (0924-0075-04) / 2 TABLET, COATED in 1 PACKET (0924-0075-00)Marketed from Feb 1, 2016
0924-0075-05009240075050092400750520 PACKET in 1 CARTON (0924-0075-05) / 2 TABLET, COATED in 1 PACKET (0924-0075-00)Marketed from Feb 1, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Physicians Care Ibuprofen
Generic name (nonproprietary)
ibuprofen 200mg
Active ingredients
Ibuprofen — 200 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
Acme United CorporationNDC labeler code 0924
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075010
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 0924-0075_42788d11-1807-dfe4-e063-6294a90a477aSPL ID 42788d11-1807-dfe4-e063-6294a90a477aSPL set ID 490c1109-dad7-4135-e054-00144ff8d46cRxCUI 310965UNII WK2XYI10QMUPC 0073577900158

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

N400924007500 followed by a unit qualifier and the quantity

Package 00924-0075-00. 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 associated with ■ headache ■ toothache ■ backache ■ menstrual cramps ■ common cold ■ muscular aches ■ minor arthritis pain Temporarily reduces fever.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0924-0075

What is NDC 0924-0075?
0924-0075 is the product NDC for Physicians Care Ibuprofen (ibuprofen 200mg), Ibuprofen 200 mg/1 tablet, coated, listed with the FDA by Acme United Corporation. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Physicians Care Ibuprofen (Ibuprofen 200mg).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Acme United Corporation, NDC labeler code 0924. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Physicians Care Ibuprofen?
1 other product NDC are listed under this name. See all Physicians Care 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 Physicians Care Ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Physicians Care Ibuprofenibuprofen 200mgIbuprofen 200 mg/1Tablet, Film coatedOralAcme United Corporation0924-007600924-0076-0000924-0076-0100924-0076-02+3 more

Other NDCs under ANDA 075010

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

FDA NDC Directory listings under ANDA 075010
ProductStrengthForm · routeLabelerProduct NDC
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWalgreen Company0363-0292
Ibuprofenibuprofen 200mgIbuprofen 200 mg/1Tablet, Film coatedOralLil' Drug Store Products, Inc.29485-9291
Direct Safety IbuprofenibuprofenIbuprofen 200 mg/1Tablet, CoatedOralConney Safety Products, LLC61245-085
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralBreeden Brothers, LLC70729-291
Henry Schein IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralHenry Schein Inc.0404-0017
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWalgreen Company0363-0291
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralH E B37808-922
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralH E B37808-921
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralGeritrex LLC54162-941
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralDOLGENCORP, LLC55910-791
Medique at Home IprinibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralSportpharm LLC85766-122
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-354
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralCHAIN DRUG MARKETING ASSOCIATION INC63868-773
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralDiscount Drug Mart53943-292
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralDiscount Drug Mart53943-291
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.66267-115
Ibuprofenibuprofen tablet, film-coatedIbuprofen 200 mg/1Tablet, Film coatedOralLil' Drug Store Products, Inc.66715-9819
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLidl US LLC71141-178
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralRite Aid Corporation11822-0291
Pain Relief IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralRite Aid Corporation11822-0292

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