FDA.reportPublic FDA data

Naproxen

Product NDC
12634-498
11-digit product format
126340498
Labeler code
12634
Product ID
12634-498_35b8ec82-7260-5925-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA075927
Marketing category
ANDA
Marketing start
2010-02-18
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
250 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
12634-498-002020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-012020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-092020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-402020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-422020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-452020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-502020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-522020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-542020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-572020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-592020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-602020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-612020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-632020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-662020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-672020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-692020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-712020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-742020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-782020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-792020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-802020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-812020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-822020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-842020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-852020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-902020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-912020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-922020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-932020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-942020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-952020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-962020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-972020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-982020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP
12634-498-992020-01-31C16284748780-19d75b9d0-f112-f424-e053-dadaa90a57ceNaproxen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-498-00Naproxen10 in 1 BOTTLETABLET102
12634-498-01Naproxen100 in 1 BOTTLETABLET1002
12634-498-09Naproxen35 in 1 BOTTLETABLET352
12634-498-40Naproxen40 in 1 BOTTLETABLET402
12634-498-42Naproxen42 in 1 BOTTLETABLET422
12634-498-45Naproxen45 in 1 BOTTLETABLET452
12634-498-50Naproxen50 in 1 BOTTLETABLET502
12634-498-52Naproxen12 in 1 BLISTER PACKTABLET122
12634-498-54Naproxen14 in 1 BLISTER PACKTABLET142
12634-498-57Naproxen20 in 1 BLISTER PACKTABLET202
12634-498-59Naproxen30 in 1 BLISTER PACKTABLET302
12634-498-60Naproxen60 in 1 BOTTLETABLET602
12634-498-61Naproxen10 in 1 BLISTER PACKTABLET102
12634-498-63Naproxen3 in 1 BLISTER PACKTABLET32
12634-498-66Naproxen6 in 1 BLISTER PACKTABLET62
12634-498-67Naproxen7 in 1 BLISTER PACKTABLET72
12634-498-69Naproxen9 in 1 BLISTER PACKTABLET92
12634-498-71Naproxen30 in 1 BOTTLETABLET302
12634-498-74Naproxen24 in 1 BOTTLETABLET242
12634-498-78Naproxen28 in 1 BOTTLETABLET282
12634-498-79Naproxen25 in 1 BOTTLETABLET252
12634-498-80Naproxen20 in 1 BOTTLETABLET202
12634-498-81Naproxen21 in 1 BOTTLETABLET212
12634-498-82Naproxen12 in 1 BOTTLETABLET122
12634-498-84Naproxen14 in 1 BOTTLETABLET142
12634-498-85Naproxen15 in 1 BOTTLETABLET152
12634-498-90Naproxen90 in 1 BOTTLETABLET902
12634-498-91Naproxen1 in 1 BLISTER PACKTABLET12
12634-498-92Naproxen2 in 1 BOTTLETABLET22
12634-498-93Naproxen3 in 1 BOTTLETABLET32
12634-498-94Naproxen4 in 1 BOTTLETABLET42
12634-498-95Naproxen5 in 1 BOTTLETABLET52
12634-498-96Naproxen6 in 1 BOTTLETABLET62
12634-498-97Naproxen7 in 1 BOTTLETABLET72
12634-498-98Naproxen8 in 1 BOTTLETABLET82
12634-498-99Naproxen9 in 1 BOTTLETABLET92

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12634-498-71EA - Each12634-4984b6a1d30-349b-454b-9d97-540cf8059ae512016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-498NAPROXEN TABLET [APOTHECA INC.]2Legacy NDC, 36 package rows20160620_35b8ec82-725f-5925-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN35b8ec82-725f-5925-e054-00144ff8d46c2
198013naproxen 250 MG Oral TabletSCD35b8ec82-725f-5925-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-498-001263404980010 in 1 BOTTLEHistorical
12634-498-0112634049801100 in 1 BOTTLEHistorical
12634-498-091263404980935 in 1 BOTTLEHistorical
12634-498-401263404984040 in 1 BOTTLEHistorical
12634-498-421263404984242 in 1 BOTTLEHistorical
12634-498-451263404984545 in 1 BOTTLEHistorical
12634-498-501263404985050 in 1 BOTTLEHistorical
12634-498-521263404985212 in 1 BLISTER PACKHistorical
12634-498-541263404985414 in 1 BLISTER PACKHistorical
12634-498-571263404985720 in 1 BLISTER PACKHistorical
12634-498-591263404985930 in 1 BLISTER PACKHistorical
12634-498-601263404986060 in 1 BOTTLEHistorical
12634-498-611263404986110 in 1 BLISTER PACKHistorical
12634-498-63126340498633 in 1 BLISTER PACKHistorical
12634-498-66126340498666 in 1 BLISTER PACKHistorical
12634-498-67126340498677 in 1 BLISTER PACKHistorical
12634-498-69126340498699 in 1 BLISTER PACKHistorical
12634-498-711263404987130 in 1 BOTTLEHistorical
12634-498-741263404987424 in 1 BOTTLEHistorical
12634-498-781263404987828 in 1 BOTTLEHistorical
12634-498-791263404987925 in 1 BOTTLEHistorical
12634-498-801263404988020 in 1 BOTTLEHistorical
12634-498-811263404988121 in 1 BOTTLEHistorical
12634-498-821263404988212 in 1 BOTTLEHistorical
12634-498-841263404988414 in 1 BOTTLEHistorical
12634-498-851263404988515 in 1 BOTTLEHistorical
12634-498-901263404989090 in 1 BOTTLEHistorical
12634-498-91126340498911 in 1 BLISTER PACKHistorical
12634-498-92126340498922 in 1 BOTTLEHistorical
12634-498-93126340498933 in 1 BOTTLEHistorical
12634-498-94126340498944 in 1 BOTTLEHistorical
12634-498-95126340498955 in 1 BOTTLEHistorical
12634-498-96126340498966 in 1 BOTTLEHistorical
12634-498-97126340498977 in 1 BOTTLEHistorical
12634-498-98126340498988 in 1 BOTTLEHistorical
12634-498-99126340498999 in 1 BOTTLEHistorical