FDA.reportPublic FDA data

Rapidol Naproxen

Product NDC
55758-048
11-digit product format
557580048
Labeler code
55758
Product ID
55758-048_4d7ad592-5b3b-e731-e063-6394a90a11e0
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Pharmadel LLC
Application
ANDA091353
Marketing category
ANDA
Marketing start
2019-10-09
Substance
NAPROXEN SODIUM
Active strength
220 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
Rapidol Naproxen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-048-02Rapidol Naproxen2 in 1 PACKETTABLET, COATED211
55758-048-24Rapidol Naproxen1 in 1 CARTONTABLET, COATED111
55758-048-24Rapidol Naproxen24 in 1 BOTTLETABLET, COATED2411
55758-048-50Rapidol Naproxen25 in 1 CARTONTABLET, COATED2511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-048RAPIDOL NAPROXEN (NAPROXEN SODIUM) TABLET, COATED [PHARMADEL LLC]10Current NDC, Legacy NDC, 4 package rows20250210_c94c4b6e-a48b-cee5-e053-2995a90a49ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNc94c4b6e-a48b-cee5-e053-2995a90a49ac11
849574naproxen sodium 220 MG Oral TabletSCDc94c4b6e-a48b-cee5-e053-2995a90a49ac11
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYc94c4b6e-a48b-cee5-e053-2995a90a49ac11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55758-048-02557580048022 TABLET, COATED in 1 PACKET (55758-048-02) 2023-10-24NoNoHistorical
55758-048-24557580048241 BOTTLE in 1 CARTON (55758-048-24) / 24 TABLET, COATED in 1 BOTTLE1 bottle2019-10-090000-00-00NoNoCurrent
55758-048-505575800485025 PACKET in 1 CARTON (55758-048-50) / 2 TABLET, COATED in 1 PACKET (55758-048-02) 25 packet2023-10-24NoNoHistorical