FDA.reportPublic FDA data

Naprelan

Product NDC
52427-274
11-digit product format
524270274
Labeler code
52427
Product ID
52427-274_17148bdd-3818-b718-fa09-07fd74b76d40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
ALMATICA PHARMA INC.
Application
NDA020353
Marketing category
NDA
Marketing start
2014-01-17
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
750 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
2023-12-31
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
52427-274-302024-01-30C16284748780-11030e364-f960-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NAPRELAN ® safely and effectively. See full prescribing information for NAPRELAN ® . NAPRELAN (naproxen sodium) Controlled-Release Tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52427-274-30Naprelan30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52427-274-30EA - Each52427-274135dfac7-0090-490d-9885-5b7e907ebe2012015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]2
AMMONIO METHACRYLATE COPOLYMER TYPE AINACTIVE INGREDIENT8GQS4E66YYNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]2
AMMONIO METHACRYLATE COPOLYMER TYPE BINACTIVE INGREDIENT161H3B14U2NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52427-274NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALMATICA PHARMA INC.]17Legacy NDC, 1 package rows20240724_e633ff0b-eab7-f167-8d08-e9236e54042b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116331NAPRELAN 375 MG 24HR Extended Release Oral TabletPSNe633ff0b-eab7-f167-8d08-e9236e54042b18
1116341NAPRELAN 500 MG 24HR Extended Release Oral TabletPSNe633ff0b-eab7-f167-8d08-e9236e54042b18
1116351NAPRELAN 750 MG 24HR Extended Release Oral TabletPSNe633ff0b-eab7-f167-8d08-e9236e54042b18
1116320naproxen sodium 375 MG 24HR Extended Release Oral TabletPSNe633ff0b-eab7-f167-8d08-e9236e54042b18
1116339naproxen sodium 500 MG 24HR Extended Release Oral TabletPSNe633ff0b-eab7-f167-8d08-e9236e54042b18
1116349naproxen sodium 750 MG 24HR Extended Release Oral TabletPSNe633ff0b-eab7-f167-8d08-e9236e54042b18
111633124 HR naproxen 375 MG Extended Release Oral Tablet [Naprelan]SBDe633ff0b-eab7-f167-8d08-e9236e54042b18
111634124 HR naproxen 500 MG Extended Release Oral Tablet [Naprelan]SBDe633ff0b-eab7-f167-8d08-e9236e54042b18
111635124 HR naproxen 750 MG Extended Release Oral Tablet [Naprelan]SBDe633ff0b-eab7-f167-8d08-e9236e54042b18
111632024 HR naproxen 375 MG Extended Release Oral TabletSCDe633ff0b-eab7-f167-8d08-e9236e54042b18
111633924 HR naproxen 500 MG Extended Release Oral TabletSCDe633ff0b-eab7-f167-8d08-e9236e54042b18
111634924 HR naproxen 750 MG Extended Release Oral TabletSCDe633ff0b-eab7-f167-8d08-e9236e54042b18
111633124 HR Naprelan 375 MG Extended Release Oral TabletSYe633ff0b-eab7-f167-8d08-e9236e54042b18
111634124 HR Naprelan 500 MG Extended Release Oral TabletSYe633ff0b-eab7-f167-8d08-e9236e54042b18
111635124 HR Naprelan 750 MG Extended Release Oral TabletSYe633ff0b-eab7-f167-8d08-e9236e54042b18
1116331Naprelan 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral TabletSYe633ff0b-eab7-f167-8d08-e9236e54042b18
1116341Naprelan 500 MG (naproxen sodium 550 MG) 24 HR Extended Release Oral TabletSYe633ff0b-eab7-f167-8d08-e9236e54042b18
1116351Naprelan 750 MG (naproxen sodium 825 MG) 24 HR Extended Release Oral TabletSYe633ff0b-eab7-f167-8d08-e9236e54042b18
1116320naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral TabletSYe633ff0b-eab7-f167-8d08-e9236e54042b18
1116339naproxen 500 MG (naproxen sodium 550 MG) 24 HR Extended Release Oral TabletSYe633ff0b-eab7-f167-8d08-e9236e54042b18
1116349naproxen 750 MG (as naproxen sodium 825 MG) 24 HR Extended Release Oral TabletSYe633ff0b-eab7-f167-8d08-e9236e54042b18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52427-274-305242702743030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-274-30) 2014-01-170000-00-00NoNoCurrent