FDA.reportPublic FDA data

Physicians Care Ibuprofen

Product NDC
0924-0076
11-digit product format
009240076
Labeler code
0924
Product ID
0924-0076_42788ef0-8f72-f5a5-e063-6294a90aff7d
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen 200mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Acme United Corporation
Application
ANDA079174
Marketing category
ANDA
Marketing start
2016-02-01
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Physicians Care Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-0076-00Physicians Care Ibuprofen2 in 1 PACKETTABLET, FILM COATED214
0924-0076-01Physicians Care Ibuprofen50 in 1 CARTONTABLET, FILM COATED5014
0924-0076-02Physicians Care Ibuprofen125 in 1 CARTONTABLET, FILM COATED12514
0924-0076-02Physicians Care Ibuprofen2 in 1 PACKETTABLET, FILM COATED214
0924-0076-03Physicians Care Ibuprofen10 in 1 CARTONTABLET, FILM COATED1014
0924-0076-04Physicians Care Ibuprofen6 in 1 CARTONTABLET, FILM COATED614
0924-0076-05Physicians Care Ibuprofen20 in 1 CARTONTABLET, FILM COATED2014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-0076PHYSICIANS CARE IBUPROFEN (IBUPROFEN 200MG) TABLET, FILM COATED [ACME UNITED CORPORATION]11Current NDC, Legacy NDC, 7 package rows20241205_490e551c-0e80-3d95-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN490e551c-0e80-3d95-e054-00144ff8d46c14
310965ibuprofen 200 MG Oral TabletSCD490e551c-0e80-3d95-e054-00144ff8d46c14
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY490e551c-0e80-3d95-e054-00144ff8d46c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0924-0076-00009240076002 TABLET, FILM COATED in 1 PACKET (0924-0076-00) 2016-02-01NoNoHistorical
0924-0076-010092400760150 PACKET in 1 CARTON (0924-0076-01) / 2 TABLET, FILM COATED in 1 PACKET (0924-0076-00) 50 packet2016-02-010000-00-00NoNoCurrent
0924-0076-0200924007602125 PACKET in 1 CARTON (0924-0076-02) / 2 TABLET, FILM COATED in 1 PACKET125 packet2016-02-010000-00-00NoNoCurrent
0924-0076-030092400760310 PACKET in 1 CARTON (0924-0076-03) / 2 TABLET, FILM COATED in 1 PACKET (0924-0076-00) 10 packet2016-02-010000-00-00NoNoCurrent
0924-0076-04009240076046 PACKET in 1 CARTON (0924-0076-04) / 2 TABLET, FILM COATED in 1 PACKET (0924-0076-00) 6 packet2016-02-01NoNoHistorical
0924-0076-050092400760520 PACKET in 1 CARTON (0924-0076-05) / 2 TABLET, FILM COATED in 1 PACKET (0924-0076-00) 20 packet2016-02-01NoNoHistorical