FDA.reportPublic FDA data

PROPRINAL

Product NDC
50332-0130
11-digit product format
503320130
Labeler code
50332
Product ID
50332-0130_accace16-6289-44cb-bbfc-99103d282fa2
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen Capsules 200 mg
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
HART Health
Application
ANDA079205
Marketing category
ANDA
Marketing start
2017-01-11
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
PROPRINAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964, 2673691

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0130PROPRINAL (IBUPROFEN CAPSULES 200 MG) CAPSULE, LIQUID FILLED [HART HEALTH]2Current NDC20241206_ec27b625-a3fa-4c5f-8134-c9373c09b3e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSNec27b625-a3fa-4c5f-8134-c9373c09b3e32
2673691Proprinal 200 MG Oral CapsulePSNec27b625-a3fa-4c5f-8134-c9373c09b3e32
2673691ibuprofen 200 MG Oral Capsule [Proprinal]SBDec27b625-a3fa-4c5f-8134-c9373c09b3e32
310964ibuprofen 200 MG Oral CapsuleSCDec27b625-a3fa-4c5f-8134-c9373c09b3e32
2673691Proprinal 200 MG Oral CapsuleSYec27b625-a3fa-4c5f-8134-c9373c09b3e32
310964ibuprofen 200 MG Oral CapsulePSN4723dd14-5d20-4a9a-b127-4237d5db59561
2673691Proprinal 200 MG Oral CapsulePSN4723dd14-5d20-4a9a-b127-4237d5db59561
2673691ibuprofen 200 MG Oral Capsule [Proprinal]SBD4723dd14-5d20-4a9a-b127-4237d5db59561
310964ibuprofen 200 MG Oral CapsuleSCD4723dd14-5d20-4a9a-b127-4237d5db59561
2673691Proprinal 200 MG Oral CapsuleSY4723dd14-5d20-4a9a-b127-4237d5db59561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50332-0130-150332013001300 PACKET in 1 BOX (50332-0130-1) / 2 CAPSULE, LIQUID FILLED in 1 PACKET300 packet2017-01-11NoNoHistorical
50332-0130-35033201300320 PACKET in 1 BAG (50332-0130-3) / 2 CAPSULE, LIQUID FILLED in 1 PACKET20 packet2017-01-11NoNoHistorical
50332-0130-45033201300440 PACKET in 1 BOX (50332-0130-4) / 2 CAPSULE, LIQUID FILLED in 1 PACKET40 packet2017-01-11NoNoHistorical
50332-0130-750332013007100 PACKET in 1 BOX (50332-0130-7) / 2 CAPSULE, LIQUID FILLED in 1 PACKET100 packet2017-01-11NoNoHistorical
50332-0130-850332013008200 PACKET in 1 BOX (50332-0130-8) / 2 CAPSULE, LIQUID FILLED in 1 PACKET200 packet2017-01-11NoNoHistorical