Tramadol Hydrochloride

Product NDC
60760-772
11-digit product format
607600772
Labeler code
60760
Product ID
60760-772_50c7ea1f-6612-746d-e063-6394a90a9f24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA203494
Marketing category
ANDA
Marketing start
2022-12-28
Substance
TRAMADOL HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tramadol Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui835603

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
c563c906-2606-457c-bb1b-5a623daed55bProduct name120210511
43a9f8f9-34aa-8ae8-719e-5489454f7720Product name520200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75Product name120190927
377068df-225f-7318-a910-a1987cdfa361Product name320170608
9457302e-0ca3-d9ff-0863-1b24b6107218Product name120140508
d5c49867-1fe9-7a44-3319-814417011d51Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-772-09Tramadol Hydrochloride9 in 1 BOTTLE, PLASTICTABLET, FILM COATED94
60760-772-20Tramadol Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED204
60760-772-30Tramadol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304
60760-772-50Tramadol Hydrochloride50 in 1 BOTTLE, PLASTICTABLET, FILM COATED504
60760-772-60Tramadol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604
60760-772-90Tramadol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-772TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, 6 package rows20230203_f2f421ab-35ae-7637-e053-2995a90a40e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNf2f421ab-35ae-7637-e053-2995a90a40e04
835603tramadol hydrochloride 50 MG Oral TabletSCDf2f421ab-35ae-7637-e053-2995a90a40e04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-772-09607600772099 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-772-09) 2022-12-28NoNoCurrent
60760-772-206076007722020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-772-20) 2023-02-02NoNoCurrent
60760-772-306076007723030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-772-30) 2022-12-28NoNoCurrent
60760-772-506076007725050 in 1 BOTTLE, PLASTICHistorical
60760-772-606076007726060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-772-60) 2023-02-02NoNoCurrent
60760-772-906076007729090 in 1 BOTTLE, PLASTICHistorical