FDA.reportPublic FDA data

Naproxen

Product NDC
50228-436
11-digit product format
502280436
Labeler code
50228
Product ID
50228-436_9af8c9f3-92e7-4301-b401-f40230af2eb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA212517
Marketing category
ANDA
Marketing start
2020-03-01
Substance
NAPROXEN
Active strength
500 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
Naproxen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198012, 198013, 198014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
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
50228-436-01Naproxen100 in 1 BOTTLETABLET1009
50228-436-05Naproxen500 in 1 BOTTLETABLET5009
50228-436-10Naproxen1000 in 1 BOTTLETABLET10009
50228-436-30Naproxen30 in 1 BOTTLETABLET309
50228-436-01Naprotin100 in 1 BOTTLETABLET100500 mg2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-436-01EA - Each50228-436a4e0c7b6-1055-45f5-9618-a2a24739489112020-04-20
50228-436-05EA - Each50228-4365225e611-4788-4429-9e5d-86a023f33fa012020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-436NAPROXEN TABLET [SCIEGEN PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 4 package rows20231109_81e22c1f-f94d-46e9-8b7d-72dc2518319e.zip
50228-436NAPROTIN (NAPROXEN , CAPSAICIN) KIT [PURETEK CORPORATION]2Current NDC, Legacy NDC20241215_dc2d2783-2a73-cb7c-e053-2995a90a9961.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN1cdcaba5-5550-40f6-94cc-b0a98cc17d3c103
198014naproxen 500 MG Oral TabletPSNd564f52d-171c-4e7d-974c-3a0e192e6c12103
198014naproxen 500 MG Oral TabletSCD1cdcaba5-5550-40f6-94cc-b0a98cc17d3c103
198014naproxen 500 MG Oral TabletSCDd564f52d-171c-4e7d-974c-3a0e192e6c12103
198014naproxen 500 MG Oral TabletPSNfa2fe6fd-c476-dd29-e053-6294a90a9e9e16
198014naproxen 500 MG Oral TabletSCDfa2fe6fd-c476-dd29-e053-6294a90a9e9e16
198013naproxen 250 MG Oral TabletPSN81e22c1f-f94d-46e9-8b7d-72dc2518319e9
198012naproxen 375 MG Oral TabletPSN81e22c1f-f94d-46e9-8b7d-72dc2518319e9
198014naproxen 500 MG Oral TabletPSN81e22c1f-f94d-46e9-8b7d-72dc2518319e9
198013naproxen 250 MG Oral TabletSCD81e22c1f-f94d-46e9-8b7d-72dc2518319e9
198012naproxen 375 MG Oral TabletSCD81e22c1f-f94d-46e9-8b7d-72dc2518319e9
198014naproxen 500 MG Oral TabletSCD81e22c1f-f94d-46e9-8b7d-72dc2518319e9
198014naproxen 500 MG Oral TabletPSNafebe3d8-97cc-3083-e053-2a95a90a0f9d8
198014naproxen 500 MG Oral TabletPSNccd95dfc-9236-4707-a715-6a12c91519ff8
198014naproxen 500 MG Oral TabletSCDafebe3d8-97cc-3083-e053-2a95a90a0f9d8
198014naproxen 500 MG Oral TabletSCDccd95dfc-9236-4707-a715-6a12c91519ff8
198014naproxen 500 MG Oral TabletPSNd0670241-f1f9-4fdf-83d4-547e7b8008116
198014naproxen 500 MG Oral TabletSCDd0670241-f1f9-4fdf-83d4-547e7b8008116
198014naproxen 500 MG Oral TabletPSN7fef9311-471b-472c-b4f2-c952a2b3a2555
198014naproxen 500 MG Oral TabletPSN1acfb8cc-6faf-4b3e-9304-4819c42de0a65
198014naproxen 500 MG Oral TabletPSNc986ba9a-6f48-8347-e053-2a95a90aa1c15
198014naproxen 500 MG Oral TabletSCD7fef9311-471b-472c-b4f2-c952a2b3a2555
198014naproxen 500 MG Oral TabletSCDc986ba9a-6f48-8347-e053-2a95a90aa1c15
198014naproxen 500 MG Oral TabletSCD1acfb8cc-6faf-4b3e-9304-4819c42de0a65
198014naproxen 500 MG Oral TabletPSN1e406e47-408a-48cc-921e-52882a11581c4
198014naproxen 500 MG Oral TabletSCD1e406e47-408a-48cc-921e-52882a11581c4
198014naproxen 500 MG Oral TabletPSNc136cf75-4ad4-8634-e053-2a95a90a53a43
198014naproxen 500 MG Oral TabletPSNe3a3e5d2-2d1e-74d3-e053-2995a90a82bf3
198014naproxen 500 MG Oral TabletSCDe3a3e5d2-2d1e-74d3-e053-2995a90a82bf3
198014naproxen 500 MG Oral TabletSCDc136cf75-4ad4-8634-e053-2a95a90a53a43
198555capsaicin 0.025 % Topical CreamPSNdc2d2783-2a73-cb7c-e053-2995a90a99612
198013naproxen 250 MG Oral TabletPSN1c5b2bc1-26bb-4f88-bded-399263c823312
198012naproxen 375 MG Oral TabletPSN1c5b2bc1-26bb-4f88-bded-399263c823312
198014naproxen 500 MG Oral TabletPSNa3323509-1fa4-41e5-893d-ac3f7ac02ccd2
198014naproxen 500 MG Oral TabletPSNb5589d2a-dfea-c6c1-e053-2995a90aca1c2
198014naproxen 500 MG Oral TabletPSNc6765b1b-d5e3-32fd-e053-2a95a90a6a532
198014naproxen 500 MG Oral TabletPSNcfa88511-40bb-4658-b606-44c68d0746b72
198014naproxen 500 MG Oral TabletPSNdc2d2783-2a73-cb7c-e053-2995a90a99612
198014naproxen 500 MG Oral TabletPSNb500bdba-946a-41ff-855c-1f2937547d012
198014naproxen 500 MG Oral TabletPSN24d44eb6-921e-4150-a6b2-81f42ced32ab2
198014naproxen 500 MG Oral TabletPSN49a00870-f580-4eb9-a95d-48fa956f147f2
198014naproxen 500 MG Oral TabletPSN1c5b2bc1-26bb-4f88-bded-399263c823312
198555capsaicin 0.25 MG/ML Topical CreamSCDdc2d2783-2a73-cb7c-e053-2995a90a99612
198013naproxen 250 MG Oral TabletSCD1c5b2bc1-26bb-4f88-bded-399263c823312
198012naproxen 375 MG Oral TabletSCD1c5b2bc1-26bb-4f88-bded-399263c823312
198014naproxen 500 MG Oral TabletSCDa3323509-1fa4-41e5-893d-ac3f7ac02ccd2
198014naproxen 500 MG Oral TabletSCDb500bdba-946a-41ff-855c-1f2937547d012
198014naproxen 500 MG Oral TabletSCDc6765b1b-d5e3-32fd-e053-2a95a90a6a532
198014naproxen 500 MG Oral TabletSCD49a00870-f580-4eb9-a95d-48fa956f147f2
198014naproxen 500 MG Oral TabletSCDcfa88511-40bb-4658-b606-44c68d0746b72
198014naproxen 500 MG Oral TabletSCD1c5b2bc1-26bb-4f88-bded-399263c823312
198014naproxen 500 MG Oral TabletSCDdc2d2783-2a73-cb7c-e053-2995a90a99612
198014naproxen 500 MG Oral TabletSCDb5589d2a-dfea-c6c1-e053-2995a90aca1c2
198014naproxen 500 MG Oral TabletSCD24d44eb6-921e-4150-a6b2-81f42ced32ab2
198555capsaicin 0.025 % Topical CreamSYdc2d2783-2a73-cb7c-e053-2995a90a99612
198014naproxen 500 MG Oral TabletPSN1431b769-5535-78d6-e063-6394a90a84231
198014naproxen 500 MG Oral TabletPSN39d34c1a-d1a8-434c-9f89-eed52e764fa61
198014naproxen 500 MG Oral TabletPSN43912294-77c9-eda8-e063-6394a90adf0a1
198014naproxen 500 MG Oral TabletPSN8c3398bd-66b1-4a14-8aaa-e4a2d6749a081
198014naproxen 500 MG Oral TabletPSNbc2c6b1e-999d-91a7-e053-2a95a90a9d1a1
198014naproxen 500 MG Oral TabletSCD39d34c1a-d1a8-434c-9f89-eed52e764fa61
198014naproxen 500 MG Oral TabletSCD43912294-77c9-eda8-e063-6394a90adf0a1
198014naproxen 500 MG Oral TabletSCD8c3398bd-66b1-4a14-8aaa-e4a2d6749a081
198014naproxen 500 MG Oral TabletSCD1431b769-5535-78d6-e063-6394a90a84231
198014naproxen 500 MG Oral TabletSCDbc2c6b1e-999d-91a7-e053-2a95a90a9d1a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-436-0150228043601100 TABLET in 1 BOTTLE (50228-436-01) 100 tablet2020-03-010000-00-00NoNoCurrent
50228-436-0550228043605500 TABLET in 1 BOTTLE (50228-436-05) 500 tablet2020-03-010000-00-00NoNoCurrent
50228-436-10502280436101000 TABLET in 1 BOTTLE (50228-436-10) 1000 tablet2020-03-010000-00-00NoNoCurrent
50228-436-305022804363030 TABLET in 1 BOTTLE (50228-436-30) 30 tablet2020-03-010000-00-00NoNoCurrent