tramadol hydrochloride

Product NDC
71335-2518
11-digit product format
713352518
Labeler code
71335
Product ID
71335-2518_e37a5865-f78e-41d4-9d0a-b7ec7bcd0807
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-2518-0tramadol hydrochloride50 in 1 BOTTLETABLET501
71335-2518-1tramadol hydrochloride30 in 1 BOTTLETABLET301
71335-2518-2tramadol hydrochloride20 in 1 BOTTLETABLET201
71335-2518-3tramadol hydrochloride90 in 1 BOTTLETABLET901
71335-2518-4tramadol hydrochloride60 in 1 BOTTLETABLET601
71335-2518-5tramadol hydrochloride120 in 1 BOTTLETABLET1201
71335-2518-6tramadol hydrochloride180 in 1 BOTTLETABLET1801
71335-2518-7tramadol hydrochloride40 in 1 BOTTLETABLET401
71335-2518-8tramadol hydrochloride100 in 1 BOTTLETABLET1001
71335-2518-9tramadol hydrochloride15 in 1 BOTTLETABLET151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2518-1EA - Each71335-2518c06c71d7-a84d-49c6-a89e-e8539abf254512025-02-10
71335-2518-2EA - Each71335-2518ab7d09af-b05a-409d-9fed-53cf6e6be0db12025-12-16
71335-2518-3EA - Each71335-2518f4157ade-4b57-45b7-8234-2e84ce02fb7412025-07-08
71335-2518-4EA - Each71335-2518c3a1fe04-0d19-403b-8961-23f62a3f494312025-02-10
71335-2518-5EA - Each71335-25185a2354c2-75fc-4e98-9de4-9ba0207c4dde12025-07-08
71335-2518-6EA - Each71335-251853b4a46a-1fdb-40c3-be9f-d01ce81ba90612025-12-16
71335-2518-9EA - Each71335-25188af8529d-1ed7-49dd-849c-5f09ed07e0d212025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2518TRAMADOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1Current NDC, 10 package rows20241105_6ebc5864-c222-4400-a9b2-f66fd6fb0da6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN6ebc5864-c222-4400-a9b2-f66fd6fb0da61
835603tramadol hydrochloride 50 MG Oral TabletSCD6ebc5864-c222-4400-a9b2-f66fd6fb0da61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2518-07133525180050 TABLET in 1 BOTTLE (71335-2518-0) 50 tablet2024-11-04NoNoHistorical
71335-2518-17133525180130 TABLET in 1 BOTTLE (71335-2518-1) 30 tablet2024-11-04NoNoHistorical
71335-2518-27133525180220 TABLET in 1 BOTTLE (71335-2518-2) 20 tablet2024-11-04NoNoHistorical
71335-2518-37133525180390 TABLET in 1 BOTTLE (71335-2518-3) 90 tablet2024-11-04NoNoHistorical
71335-2518-47133525180460 TABLET in 1 BOTTLE (71335-2518-4) 60 tablet2024-11-04NoNoHistorical
71335-2518-571335251805120 TABLET in 1 BOTTLE (71335-2518-5) 120 tablet2024-11-04NoNoHistorical
71335-2518-671335251806180 TABLET in 1 BOTTLE (71335-2518-6) 180 tablet2024-11-04NoNoHistorical
71335-2518-77133525180740 TABLET in 1 BOTTLE (71335-2518-7) 40 tablet2024-11-04NoNoHistorical
71335-2518-871335251808100 TABLET in 1 BOTTLE (71335-2518-8) 100 tablet2024-11-04NoNoHistorical
71335-2518-97133525180915 TABLET in 1 BOTTLE (71335-2518-9) 15 tablet2024-11-04NoNoHistorical