FDA.reportPublic FDA data

Methocarbamol and Aspirin

Product NDC
50564-490
11-digit product format
505640490
Labeler code
50564
Product ID
50564-490_518282ce-77df-411f-85d4-ada698987b2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol and Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
Jerome Stevens Pharmaceuticals, Inc.
Application
ANDA081145
Marketing category
ANDA
Marketing start
1995-01-31
Marketing end
0000-00-00
Substance
METHOCARBAMOL; ASPIRIN
Active strength
400 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]
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
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
492965be-47bc-38cf-57c4-5c5e0343abe5Product name620211028
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205
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
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50564-490-012026-01-29C16284748780-1f386c649-a250-0266-e053-dadaa90a7c1aMethocarbamol and Aspirin Tablets
50564-490-052026-01-29C16284748780-1f386c649-a250-0266-e053-dadaa90a7c1aMethocarbamol and Aspirin Tablets
50564-490-012024-12-05C16284748780-1f386c649-a250-0266-e053-dadaa90a7c1aMethocarbamol and Aspirin Tablets
50564-490-052024-12-05C16284748780-1f386c649-a250-0266-e053-dadaa90a7c1aMethocarbamol and Aspirin Tablets
50564-490-012023-01-30C16284748780-1f386c649-a250-0266-e053-dadaa90a7c1aMethocarbamol and Aspirin Tablets
50564-490-052023-01-30C16284748780-1f386c649-a250-0266-e053-dadaa90a7c1aMethocarbamol and Aspirin Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50564-490-01Methocarbamol and Aspirin100 in 1 BOTTLETABLET1004
50564-490-05Methocarbamol and Aspirin500 in 1 BOTTLETABLET5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50564-490METHOCARBAMOL AND ASPIRIN TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]4Legacy NDC, 2 package rows20241207_055edd83-bab7-486a-a2b8-dad9f3bae916.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197945methocarbamol 400 MG / aspirin 325 MG Oral TabletPSN055edd83-bab7-486a-a2b8-dad9f3bae9164
197945aspirin 325 MG / methocarbamol 400 MG Oral TabletSCD055edd83-bab7-486a-a2b8-dad9f3bae9164
197945ASA 325 MG / Methocarbamol 400 MG Oral TabletSY055edd83-bab7-486a-a2b8-dad9f3bae9164

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50564-490-0150564049001100 TABLET in 1 BOTTLE (50564-490-01) 100 tablet1995-01-310000-00-00NoNoCurrent
50564-490-0550564049005500 TABLET in 1 BOTTLE (50564-490-05) 500 tablet1995-01-310000-00-00NoNoCurrent