FDA.reportPublic FDA data

tramadol hydrochloride

Product NDC
60760-588
11-digit product format
607600588
Labeler code
60760
Product ID
60760-588_3fa66c6a-130c-7945-e063-6294a90af0bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA202075
Marketing category
ANDA
Marketing start
2018-03-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
tramadol hydrochloride
Listing expiration
2026-12-31

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
60760-588-09tramadol hydrochloride9 in 1 BOTTLE, PLASTICTABLET95
60760-588-20tramadol hydrochloride20 in 1 BOTTLE, PLASTICTABLET205
60760-588-30tramadol hydrochloride30 in 1 BOTTLE, PLASTICTABLET305
60760-588-50tramadol hydrochloride50 in 1 BOTTLE, PLASTICTABLET505
60760-588-60tramadol hydrochloride60 in 1 BOTTLE, PLASTICTABLET605
60760-588-90tramadol hydrochloride90 in 1 BOTTLE, PLASTICTABLET905
60760-588-92tramadol hydrochloride120 in 1 BOTTLE, PLASTICTABLET1205
60760-588-98tramadol hydrochloride180 in 1 BOTTLE, PLASTICTABLET1805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-588-09EA - Each60760-5888044d3d1-d90b-409e-8d4d-ea3e128cd54c12025-05-14
60760-588-20EA - Each60760-58836eaea44-cbe1-4348-9f25-e8b0c2f1ee1c12024-04-05
60760-588-30EA - Each60760-5887bf17a3a-ccba-4d08-8dc6-a1f40e204a5312023-12-05
60760-588-50EA - Each60760-5889313f527-6288-4252-843a-075e7cff9d4712023-12-05
60760-588-60EA - Each60760-58836d78c0e-97d4-475f-b0d0-64e94a261b1212024-07-12
60760-588-90EA - Each60760-58819faefea-5efd-49d4-9d6c-1b3dcd11d19912023-12-05
60760-588-92EA - Each60760-588d9c07bec-8afa-492e-a0f0-80ee36a8642a12025-11-13
60760-588-98EA - Each60760-58846bce7e8-015a-48a3-8a9f-e4ce6e92f26b12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-588TRAMADOL HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]4Current NDC, 8 package rows20250315_087a7afe-ac1f-a201-e063-6394a90a260d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN087a7afe-ac1f-a201-e063-6394a90a260d5
835603tramadol hydrochloride 50 MG Oral TabletSCD087a7afe-ac1f-a201-e063-6394a90a260d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-588-09607600588099 TABLET in 1 BOTTLE, PLASTIC (60760-588-09) 9 tablet2025-03-12NoNoCurrent
60760-588-206076005882020 TABLET in 1 BOTTLE, PLASTIC (60760-588-20) 20 tablet2024-03-15NoNoCurrent
60760-588-306076005883030 TABLET in 1 BOTTLE, PLASTIC (60760-588-30) 30 tablet2023-10-06NoNoCurrent
60760-588-506076005885050 TABLET in 1 BOTTLE, PLASTIC (60760-588-50) 50 tablet2023-10-06NoNoCurrent
60760-588-606076005886060 TABLET in 1 BOTTLE, PLASTIC (60760-588-60) 60 tablet2024-03-29NoNoCurrent
60760-588-906076005889090 TABLET in 1 BOTTLE, PLASTIC (60760-588-90) 90 tablet2023-10-06NoNoCurrent
60760-588-9260760058892120 TABLET in 1 BOTTLE, PLASTIC (60760-588-92) 120 tablet2025-09-25NoNoCurrent
60760-588-9860760058898180 TABLET in 1 BOTTLE, PLASTIC (60760-588-98) 180 tablet2025-03-12NoNoCurrent