FDA.reportPublic FDA data

tramadol hydrochloride

Product NDC
68788-8717
11-digit product format
687888717
Labeler code
68788
Product ID
68788-8717_12af9122-aed2-461a-b7fc-e48a030d59a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202075
Marketing category
ANDA
Marketing start
2024-07-18
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
68788-8717-1tramadol hydrochloride100 in 1 BOTTLETABLET1002
68788-8717-2tramadol hydrochloride20 in 1 BOTTLETABLET202
68788-8717-3tramadol hydrochloride30 in 1 BOTTLETABLET302
68788-8717-4tramadol hydrochloride40 in 1 BOTTLETABLET402
68788-8717-5tramadol hydrochloride15 in 1 BOTTLETABLET152
68788-8717-6tramadol hydrochloride60 in 1 BOTTLETABLET602
68788-8717-7tramadol hydrochloride50 in 1 BOTTLETABLET502
68788-8717-8tramadol hydrochloride120 in 1 BOTTLETABLET1202
68788-8717-9tramadol hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8717-1EA - Each68788-871784664a90-422c-4f9d-a008-875e31f3abe112024-09-09
68788-8717-2EA - Each68788-8717c825ec0b-77f0-451e-9234-f714414fec2f12024-09-09
68788-8717-3EA - Each68788-871781ac1ab1-1446-4704-aede-f43832c106ef12024-09-09
68788-8717-4EA - Each68788-871771734899-1661-442c-af43-b364273d382112024-09-09
68788-8717-5EA - Each68788-871721fd3d29-9781-49ee-bd2f-6b0e8452621c12024-09-09
68788-8717-6EA - Each68788-871757982710-5243-471d-b53c-f87b5b3b5b9212024-09-09
68788-8717-7EA - Each68788-87176bc8e6c8-3d6b-4f28-a93a-2676c76a4fe812024-09-09
68788-8717-8EA - Each68788-871755e3bf24-7378-4270-9b03-27414db3d8b112024-09-09
68788-8717-9EA - Each68788-8717b9786e62-87ea-4a99-be3b-96282489f6df12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8717TRAMADOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 9 package rows20240730_05f8e06b-f3eb-4cb2-aee5-bd0b03884178.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN05f8e06b-f3eb-4cb2-aee5-bd0b038841782
835603tramadol hydrochloride 50 MG Oral TabletSCD05f8e06b-f3eb-4cb2-aee5-bd0b038841782

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8717-168788871701100 TABLET in 1 BOTTLE (68788-8717-1) 100 tablet2024-07-18NoNoCurrent
68788-8717-26878887170220 TABLET in 1 BOTTLE (68788-8717-2) 20 tablet2024-07-18NoNoCurrent
68788-8717-36878887170330 TABLET in 1 BOTTLE (68788-8717-3) 30 tablet2024-07-18NoNoCurrent
68788-8717-46878887170440 TABLET in 1 BOTTLE (68788-8717-4) 40 tablet2024-07-18NoNoCurrent
68788-8717-56878887170515 TABLET in 1 BOTTLE (68788-8717-5) 15 tablet2024-07-18NoNoCurrent
68788-8717-66878887170660 TABLET in 1 BOTTLE (68788-8717-6) 60 tablet2024-07-18NoNoCurrent
68788-8717-76878887170750 TABLET in 1 BOTTLE (68788-8717-7) 50 tablet2024-07-18NoNoCurrent
68788-8717-868788871708120 TABLET in 1 BOTTLE (68788-8717-8) 120 tablet2024-07-18NoNoCurrent
68788-8717-96878887170990 TABLET in 1 BOTTLE (68788-8717-9) 90 tablet2024-07-18NoNoCurrent