FDA.reportPublic FDA data

Dover Addaprin

Product NDC
47682-614
11-digit product format
476820614
Labeler code
47682
Product ID
47682-614_3e5d4984-a2e6-a9fc-e063-6394a90a4396
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
ANDA075010
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
Dover Addaprin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965, 900434, 900438

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
47682-614-13Dover Addaprin250 in 1 BOXTABLET, FILM COATED25024
47682-614-99Dover Addaprin2 in 1 PACKETTABLET, FILM COATED224

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47682-614-13EA - Each47682-61484aeaa7c-9125-42db-ba42-c96da0081cda12020-02-13
47682-614-99EA - Each47682-614baa7bca3-998c-4cb4-bb81-4538ac02bfaf12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-614MEDIQUE IPRIN (IBUPROFEN) TABLET, FILM COATED DOVER ADDAPRIN (IBUPROFEN) TABLET, FILM COATED MEDI-FIRST IBUPROFEN (IBUPROFEN) TABLET, FILM COATED MEDI-FIRST PLUS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED OTIS CLAPP ULTRAPRIN (IBUPROFEN) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]23Current NDC, Legacy NDC, 2 package rows20240915_2910b50b-c8de-382b-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900434Addaprin 200 MG Oral TabletPSN2910b50b-c8de-382b-e054-00144ff88e8824
310965ibuprofen 200 MG Oral TabletPSN2910b50b-c8de-382b-e054-00144ff88e8824
900438Ultraprin 200 MG Oral TabletPSN2910b50b-c8de-382b-e054-00144ff88e8824
900434ibuprofen 200 MG Oral Tablet [Addaprin]SBD2910b50b-c8de-382b-e054-00144ff88e8824
900438ibuprofen 200 MG Oral Tablet [Ultraprin]SBD2910b50b-c8de-382b-e054-00144ff88e8824
310965ibuprofen 200 MG Oral TabletSCD2910b50b-c8de-382b-e054-00144ff88e8824
900434Addaprin 200 MG Oral TabletSY2910b50b-c8de-382b-e054-00144ff88e8824
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY2910b50b-c8de-382b-e054-00144ff88e8824
900438Ultraprin 200 MG Oral TabletSY2910b50b-c8de-382b-e054-00144ff88e8824

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-614-1347682061413250 PACKET in 1 BOX (47682-614-13) / 2 TABLET, FILM COATED in 1 PACKET (47682-614-99) 250 packet2017-01-260000-00-00NoNoCurrent
47682-614-99476820614992 in 1 PACKETHistorical