Over-the-counter drug · ANDA

Physicians Care Ibuprofen (Ibuprofen 200mg) NDC 0924-0076

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

NDC codes

FDA NDC Directory
Product NDC (as listed)0924-0076Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00924-0076Add 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
0924-0076-0000924007600009240076002 TABLET, FILM COATED in 1 PACKET (0924-0076-00)Marketed from Feb 1, 2016
0924-0076-01009240076010092400760150 PACKET in 1 CARTON (0924-0076-01) / 2 TABLET, FILM COATED in 1 PACKET (0924-0076-00)Marketed from Feb 1, 2016
0924-0076-020092400760200924007602125 PACKET in 1 CARTON (0924-0076-02) / 2 TABLET, FILM COATED in 1 PACKETMarketed from Feb 1, 2016
0924-0076-03009240076030092400760310 PACKET in 1 CARTON (0924-0076-03) / 2 TABLET, FILM COATED in 1 PACKET (0924-0076-00)Marketed from Feb 1, 2016
0924-0076-0400924007604009240076046 PACKET in 1 CARTON (0924-0076-04) / 2 TABLET, FILM COATED in 1 PACKET (0924-0076-00)Marketed from Feb 1, 2016
0924-0076-05009240076050092400760520 PACKET in 1 CARTON (0924-0076-05) / 2 TABLET, FILM COATED in 1 PACKET (0924-0076-00)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, Film 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 079174
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 0924-0076_42788ef0-8f72-f5a5-e063-6294a90aff7dSPL ID 42788ef0-8f72-f5a5-e063-6294a90aff7dSPL set ID 490e551c-0e80-3d95-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

N400924007600 followed by a unit qualifier and the quantity

Package 00924-0076-00. 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 0924-0076

What is NDC 0924-0076?
0924-0076 is the product NDC for Physicians Care Ibuprofen (ibuprofen 200mg), Ibuprofen 200 mg/1 tablet, film 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, CoatedOralAcme United Corporation0924-007500924-0075-0000924-0075-0100924-0075-02+3 more

Other NDCs under ANDA 079174

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

FDA NDC Directory listings under ANDA 079174
ProductStrengthForm · routeLabelerProduct NDC
Dover AddaprinibuprofenIbuprofen 200 mg/1Tablet, CoatedOralUnifirst First Aid Corporation47682-714
IbuprofenIbuprofen 200 mg/1TabletOralBETTER LIVING BRANDS LLC.21130-396
Medique IprinibuprofenIbuprofen 200 mg/1Tablet, CoatedOralUnifirst First Aid Corporation47682-700
Medi-First Plus IbuprofenibuprofenIbuprofen 200 mg/1Tablet, CoatedOralUnifirst First Aid Corporation47682-709
Pain Relief - Ibuprofen 200 mgibuprofenIbuprofen 200 mg/1Tablet, CoatedOralHealth Pharma USA LLC71679-111
Green Guard Ibuprofen ReliefibuprofenIbuprofen 200 mg/1Tablet, CoatedOralUnifirst First Aid47682-710
Medi-First IbuprofenibuprofenIbuprofen 200 mg/1Tablet, CoatedOralUnifirst First Aid Corporation47682-718
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralMarc Glassman, Inc.68998-109
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralMarc Glassman, Inc.68998-110
IbuprofenIbuprofen 200 mg/1TabletOralGranules USA, Inc.69848-011
IbuprofenIbuprofen 200 mg/1TabletOralGranules USA, Inc.69848-012
Direct Safety IbuprofenibuprofenIbuprofen 200 mg/1Tablet, CoatedOralConney Safety Products, LLC61245-084
Lil Drug Store IbuprofenibuprofenIbuprofen 200 mg/1TabletOralLil Drug Store Products, Inc66715-6839
Medique at Home IprinibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralUnifirst First Aid Corporation47682-783
Fast Pain ReliefibuprofenIbuprofen 200 mg/1Tablet, CoatedOralHealthLife of USA LLC69517-111
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralAMERIFOODS TRADING COMPANY61504-109
IbuprofenIbuprofen 200 mg/1TabletOralRETAIL BUSINESS SERVICES,LLC.72476-365
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralAMERIFOODS TRADING COMPANY61504-110
IbuprofenIbuprofen 200 mg/1TabletOralRetail Business Services, LLC72476-366
Ibuwin ForteibuprofenIbuprofen 200 mg/1TabletOralOPMX LLC69729-157

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