FDA.reportPublic FDA data

Naproxen

Product NDC
12634-684
11-digit product format
126340684
Labeler code
12634
Product ID
12634-684_27fec1d8-54db-4fed-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA078250
Marketing category
ANDA
Marketing start
2007-07-01
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
2019-12-31
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
12634-684-002020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-012020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-402020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-542020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-552020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-572020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-582020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-592020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-602020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-612020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-662020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-712020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-742020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-802020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-812020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-842020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-912020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
12634-684-962020-01-31C16284748780-19d75b9d1-0444-f424-e053-dadaa90a57ceNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-684-00Naproxen10 in 1 BOTTLETABLET105
12634-684-01Naproxen100 in 1 BOTTLETABLET1005
12634-684-40Naproxen40 in 1 BOTTLETABLET405
12634-684-54Naproxen14 in 1 BLISTER PACKTABLET145
12634-684-55Naproxen15 in 1 BLISTER PACKTABLET155
12634-684-57Naproxen20 in 1 BLISTER PACKTABLET205
12634-684-58Naproxen28 in 1 BLISTER PACKTABLET285
12634-684-59Naproxen30 in 1 BLISTER PACKTABLET305
12634-684-60Naproxen60 in 1 BOTTLETABLET605
12634-684-61Naproxen10 in 1 BLISTER PACKTABLET105
12634-684-66Naproxen6 in 1 BLISTER PACKTABLET65
12634-684-71Naproxen30 in 1 BOTTLETABLET305
12634-684-74Naproxen24 in 1 BOTTLETABLET245
12634-684-80Naproxen20 in 1 BOTTLETABLET205
12634-684-81Naproxen21 in 1 BOTTLETABLET215
12634-684-84Naproxen14 in 1 BOTTLETABLET145
12634-684-91Naproxen1 in 1 BLISTER PACKTABLET15
12634-684-96Naproxen6 in 1 BOTTLETABLET65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12634-684-60EA - Each12634-6848e758dbc-96c7-41ec-9ec5-a1436474259512016-01-13
12634-684-71EA - Each12634-6849e04fa20-d34b-4bc1-b493-b6d2436e52b012016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-684NAPROXEN TABLET [APOTHECA INC.]5Legacy NDC, 18 package rows20151229_27ab4f1a-2f2b-150c-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN27ab4f1a-2f2b-150c-e054-00144ff8d46c5
198014naproxen 500 MG Oral TabletSCD27ab4f1a-2f2b-150c-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-684-001263406840010 in 1 BOTTLEHistorical
12634-684-0112634068401100 in 1 BOTTLEHistorical
12634-684-401263406844040 in 1 BOTTLEHistorical
12634-684-541263406845414 in 1 BLISTER PACKHistorical
12634-684-551263406845515 in 1 BLISTER PACKHistorical
12634-684-571263406845720 in 1 BLISTER PACKHistorical
12634-684-581263406845828 in 1 BLISTER PACKHistorical
12634-684-591263406845930 in 1 BLISTER PACKHistorical
12634-684-601263406846060 in 1 BOTTLEHistorical
12634-684-611263406846110 in 1 BLISTER PACKHistorical
12634-684-66126340684666 in 1 BLISTER PACKHistorical
12634-684-711263406847130 in 1 BOTTLEHistorical
12634-684-741263406847424 in 1 BOTTLEHistorical
12634-684-801263406848020 in 1 BOTTLEHistorical
12634-684-811263406848121 in 1 BOTTLEHistorical
12634-684-841263406848414 in 1 BOTTLEHistorical
12634-684-91126340684911 in 1 BLISTER PACKHistorical
12634-684-96126340684966 in 1 BOTTLEHistorical