Orphenadrine Citrate Aspirin Caffeine

Product NDC
50564-554
11-digit product format
505640554
Labeler code
50564
Product ID
50564-554_71f2aff4-c5dd-4a71-b740-30a94acc9e10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Orphenadrine Citrate, Aspirin, Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Jerome Stevens Pharmaceuticals, Inc.
Application
ANDA074988
Marketing category
ANDA
Marketing start
1999-04-30
Marketing end
0000-00-00
Substance
ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE
Active strength
25 mg/1; mg/1; mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50564-554-01Orphenadrine Citrate Aspirin Caffeine100 in 1 BOTTLETABLET1004
50564-554-05Orphenadrine Citrate Aspirin Caffeine500 in 1 BOTTLETABLET5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50564-554ORPHENADRINE CITRATE ASPIRIN CAFFEINE (ORPHENADRINE CITRATE, ASPIRIN, CAFFEINE) TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]4Legacy NDC, 2 package rows20241207_b49dd596-1f6a-4ff7-8079-e55bbcca8fbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994528orphenadrine citrate 25 MG / aspirin 385 MG / caffeine 30 MG Oral TabletPSNb49dd596-1f6a-4ff7-8079-e55bbcca8fbd4
994535orphenadrine citrate 50 MG / aspirin 770 MG / caffeine 60 MG Oral TabletPSNb49dd596-1f6a-4ff7-8079-e55bbcca8fbd4
994528aspirin 385 MG / caffeine 30 MG / orphenadrine citrate 25 MG Oral TabletSCDb49dd596-1f6a-4ff7-8079-e55bbcca8fbd4
994535aspirin 770 MG / caffeine 60 MG / orphenadrine citrate 50 MG Oral TabletSCDb49dd596-1f6a-4ff7-8079-e55bbcca8fbd4
994528ASA 385 MG / Caffeine 30 MG / Orphenadrine Citrate 25 MG Oral TabletSYb49dd596-1f6a-4ff7-8079-e55bbcca8fbd4
994535ASA 770 MG / caffeine 60 MG / orphenadrine citrate 50 MG Oral TabletSYb49dd596-1f6a-4ff7-8079-e55bbcca8fbd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50564-554-0150564055401100 TABLET in 1 BOTTLE (50564-554-01) 100 tablet1999-04-300000-00-00NoNoCurrent
50564-554-0550564055405500 TABLET in 1 BOTTLE (50564-554-05) 500 tablet1999-04-300000-00-00NoNoCurrent