FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
70518-3824
11-digit product format
705183824
Labeler code
70518
Product ID
70518-3824_50fd006e-7dd8-6f88-e063-6394a90ad9e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208708
Marketing category
ANDA
Marketing start
2023-08-07
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
70518-3824-0Tramadol Hydrochloride30 in 1 BLISTER PACKTABLET, COATED308
70518-3824-1Tramadol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, COATED608
70518-3824-2Tramadol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, COATED908
70518-3824-3Tramadol Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, COATED1808
70518-3824-4Tramadol Hydrochloride120 in 1 BOTTLE, PLASTICTABLET, COATED1208
70518-3824-5Tramadol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, COATED308
70518-3824-6Tramadol Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, COATED1008
70518-3824-7Tramadol Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, COATED1808
70518-3824-8Tramadol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3824TRAMADOL HYDROCHLORIDE TABLET, COATED [REMEDYREPACK INC.]5Current NDC, 9 package rows20250110_5199132e-745e-46a0-8068-e06d1bca5c61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN5199132e-745e-46a0-8068-e06d1bca5c618
835603tramadol hydrochloride 50 MG Oral TabletSCD5199132e-745e-46a0-8068-e06d1bca5c618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3824-07051838240030 TABLET, COATED in 1 BLISTER PACK (70518-3824-0) 2023-08-07NoNoCurrent
70518-3824-17051838240160 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3824-1) 2023-08-08NoNoCurrent
70518-3824-27051838240290 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3824-2) 2023-08-18NoNoCurrent
70518-3824-370518382403180 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3824-3) 2023-08-18NoNoCurrent
70518-3824-470518382404120 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3824-4) 2023-08-31NoNoCurrent
70518-3824-57051838240530 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3824-5) 2023-10-11NoNoCurrent
70518-3824-670518382406100 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3824-6) 2025-12-18NoNoCurrent
70518-3824-770518382407180 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3824-7) 2026-05-03NoNoCurrent
70518-3824-87051838240890 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3824-8) 2026-05-03NoNoCurrent