FDA.reportPublic FDA data

Xpect Ibuprofen

Product NDC
42961-203
11-digit product format
429610203
Labeler code
42961
Product ID
42961-203_77832fdf-dab0-411a-87e8-3db927d5bc07
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Cintas Corporation
Application
ANDA079174
Marketing category
ANDA
Marketing start
2021-02-27
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Xpect Ibuprofen
Listing expiration
2027-12-31

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
42961-203-04Xpect Ibuprofen2 in 1 PACKETTABLET28
42961-203-05Xpect Ibuprofen100 in 1 BOXTABLET1008
42961-203-06Xpect Ibuprofen250 in 1 BOXTABLET2508
42961-203-07Xpect Ibuprofen25 in 1 BAGTABLET258
42961-203-08Xpect Ibuprofen50 in 1 BOXTABLET508
42961-203-09Xpect Ibuprofen125 in 1 BOXTABLET1258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-203XPECT IBUPROFEN (IBUPROFEN) TABLET [CINTAS CORPORATION]6Current NDC, Legacy NDC, 6 package rows20241226_976ba88a-6428-40d1-a2fd-eac64963ba1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN976ba88a-6428-40d1-a2fd-eac64963ba1d8
310965ibuprofen 200 MG Oral TabletSCD976ba88a-6428-40d1-a2fd-eac64963ba1d8
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY976ba88a-6428-40d1-a2fd-eac64963ba1d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42961-203-0242961020302250 PACKET in 1 BOX (42961-203-02) > 2 TABLET in 1 PACKET (42961-203-01) 250 packet2021-02-270000-00-00NoNoCurrent
42961-203-04429610203042 in 1 PACKETHistorical
42961-203-0542961020305100 PACKET in 1 BOX (42961-203-05) > 2 TABLET in 1 PACKET (42961-203-04) 100 packet2022-12-310000-00-00NoNoCurrent
42961-203-0642961020306250 PACKET in 1 BOX (42961-203-06) > 2 TABLET in 1 PACKET (42961-203-04) 250 packet2021-02-270000-00-00NoNoCurrent
42961-203-074296102030725 PACKET in 1 BAG (42961-203-07) / 2 TABLET in 1 PACKET (42961-203-04) 25 packet2025-09-23NoNoHistorical
42961-203-084296102030850 PACKET in 1 BOX (42961-203-08) / 2 TABLET in 1 PACKET (42961-203-04) 50 packet2025-09-23NoNoHistorical
42961-203-0942961020309125 PACKET in 1 BOX (42961-203-09) / 2 TABLET in 1 PACKET (42961-203-04) 125 packet2025-09-23NoNoHistorical