FDA.reportPublic FDA data

NAPROXEN

Product NDC
61919-376
11-digit product format
619190376
Labeler code
61919
Product ID
61919-376_a873e905-7ab2-f1ec-e053-2995a90a8df6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078250
Marketing category
ANDA
Marketing start
2019-08-22
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-376-142025-01-30C16284748780-12cef2736-a29a-d83d-e063-dadaa90ab31fNAPROXEN
61919-376-202025-01-30C16284748780-12cef2736-9830-d83d-e063-dadaa90ab31fNAPROXEN
61919-376-282025-01-30C16284748780-12cef2736-64b0-d83d-e063-dadaa90ab31fNAPROXEN
61919-376-302025-01-30C16284748780-12cef2736-64b0-d83d-e063-dadaa90ab31fNAPROXEN
61919-376-452025-01-30C16284748780-12cef2736-76d4-d83d-e063-dadaa90ab31fNAPROXEN
61919-376-602025-01-30C16284748780-12cef2736-a3af-d83d-e063-dadaa90ab31fNAPROXEN
61919-376-902025-01-30C16284748780-12cef2736-a301-d83d-e063-dadaa90ab31fNAPROXEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-376-60NAPROXEN60 in 1 BOTTLETABLET603
61919-376-28NAPROXEN28 in 1 BOTTLETABLET282
61919-376-30NAPROXEN30 in 1 BOTTLETABLET302
61919-376-14NAPROXEN14 in 1 BOTTLETABLET141
61919-376-20NAPROXEN20 in 1 BOTTLETABLET201
61919-376-45NAPROXEN45 in 1 BOTTLETABLET451
61919-376-90NAPROXEN90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-376-14EA - Each61919-3768bec76d1-ed24-4254-a4c2-b63cb9f52e8c12019-09-05
61919-376-20EA - Each61919-37694c9c4d5-7241-49fc-aa96-308755e93c3212019-09-05
61919-376-28EA - Each61919-376957c0a6d-b42f-4d3e-9410-b6e9857e72e312020-07-13
61919-376-30EA - Each61919-37671bded0f-f42e-4100-8fb6-6794f921b9d512019-09-05
61919-376-45EA - Each61919-3768b13b721-9c17-4b0d-81e7-61c7cb93846112019-09-05
61919-376-60EA - Each61919-37607323da5-4ee4-4acb-9816-32b9f181e07512019-03-12
61919-376-90EA - Each61919-376262c4aa6-36b3-4a44-a627-5037193d934b12019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [DIRECT RX]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [DIRECT RX]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [DIRECT RX]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-376NAPROXEN TABLET [DIRECT RX]3Legacy NDC, 1 package rows20190306_686df0dd-42ac-4cd7-b838-51b172b06e0b.zip
61919-376NAPROXEN TABLET [DIRECT_RX]2Legacy NDC, 2 package rows20200620_90b9ec56-d687-2746-e053-2995a90ae15a.zip
61919-376NAPROXEN TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190823_90b6672d-05f5-a6c3-e053-2a95a90a49f0.zip
61919-376NAPROXEN TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190823_90b56ea3-7620-733a-e053-2995a90a11d8.zip
61919-376NAPROXEN TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190823_90b5b879-d29e-c79b-e053-2a95a90a64fc.zip
61919-376NAPROXEN TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190823_90b6b574-9b0d-517d-e053-2995a90a4556.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN686df0dd-42ac-4cd7-b838-51b172b06e0b3
198014naproxen 500 MG Oral TabletSCD686df0dd-42ac-4cd7-b838-51b172b06e0b3
198014naproxen 500 MG Oral TabletPSN90b9ec56-d687-2746-e053-2995a90ae15a2
198014naproxen 500 MG Oral TabletSCD90b9ec56-d687-2746-e053-2995a90ae15a2
198014naproxen 500 MG Oral TabletPSN90b56ea3-7620-733a-e053-2995a90a11d81
198014naproxen 500 MG Oral TabletPSN90b5b879-d29e-c79b-e053-2a95a90a64fc1
198014naproxen 500 MG Oral TabletPSN90b6672d-05f5-a6c3-e053-2a95a90a49f01
198014naproxen 500 MG Oral TabletPSN90b6b574-9b0d-517d-e053-2995a90a45561
198014naproxen 500 MG Oral TabletSCD90b56ea3-7620-733a-e053-2995a90a11d81
198014naproxen 500 MG Oral TabletSCD90b5b879-d29e-c79b-e053-2a95a90a64fc1
198014naproxen 500 MG Oral TabletSCD90b6672d-05f5-a6c3-e053-2a95a90a49f01
198014naproxen 500 MG Oral TabletSCD90b6b574-9b0d-517d-e053-2995a90a45561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-376-146191903761414 TABLET in 1 BOTTLE (61919-376-14) 14 tablet2019-08-220000-00-00NoNoCurrent
61919-376-206191903762020 TABLET in 1 BOTTLE (61919-376-20) 20 tablet2019-08-220000-00-00NoNoCurrent
61919-376-286191903762828 TABLET in 1 BOTTLE (61919-376-28) 28 tablet2019-08-220000-00-00NoNoCurrent
61919-376-306191903763030 TABLET in 1 BOTTLE (61919-376-30) 30 tablet2019-08-220000-00-00NoNoCurrent
61919-376-456191903764545 TABLET in 1 BOTTLE (61919-376-45) 45 tablet2019-08-220000-00-00NoNoCurrent
61919-376-606191903766060 TABLET in 1 BOTTLE (61919-376-60) 60 tablet2017-11-010000-00-00NoNoCurrent
61919-376-906191903769090 TABLET in 1 BOTTLE (61919-376-90) 90 tablet2019-08-220000-00-00NoNoCurrent