FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
68788-4040
11-digit product format
687884040
Labeler code
68788
Product ID
68788-4040_f558c59c-cbd4-4b17-9a3d-b014ad09bbb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA211825
Marketing category
ANDA
Marketing start
2025-10-13
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
68788-4040-1Tramadol Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
68788-4040-2Tramadol Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED201
68788-4040-3Tramadol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
68788-4040-4Tramadol Hydrochloride40 in 1 BOTTLE, PLASTICTABLET, FILM COATED401
68788-4040-5Tramadol Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED151
68788-4040-6Tramadol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
68788-4040-7Tramadol Hydrochloride50 in 1 BOTTLE, PLASTICTABLET, FILM COATED501
68788-4040-8Tramadol Hydrochloride120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1201
68788-4040-9Tramadol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4040-1EA - Each68788-404056d3ea0a-36cf-4e91-bb22-78dfa1f64c8c12026-01-08
68788-4040-2EA - Each68788-40409f7dc656-6c27-4988-8c79-049153b3ae9012026-01-08
68788-4040-3EA - Each68788-40405ef13fd9-aba2-4fd7-9730-a76c3cbfb77412026-01-08
68788-4040-4EA - Each68788-4040a4f2b9b9-cd4f-417d-81a1-ba266269e2ea12026-01-08
68788-4040-5EA - Each68788-40407227ae73-b9c4-4926-a7fc-4ef1a001c49b12026-01-08
68788-4040-6EA - Each68788-4040f11736e3-dafb-427c-873c-a2ba8d8b5e4712026-01-08
68788-4040-7EA - Each68788-404019575d96-6094-4a53-961d-91ea28a7ee1d12026-01-08
68788-4040-8EA - Each68788-4040b24cd753-81f2-46b8-8b2d-86f6536aa10312026-01-08
68788-4040-9EA - Each68788-4040850e9165-7be4-4cb0-a988-58e43719f71012026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNf558c59c-cbd4-4b17-9a3d-b014ad09bbb11
835603tramadol hydrochloride 50 MG Oral TabletSCDf558c59c-cbd4-4b17-9a3d-b014ad09bbb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4040-168788404001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-1) 2025-10-13NoNoCurrent
68788-4040-26878840400220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-2) 2025-10-13NoNoCurrent
68788-4040-36878840400330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-3) 2025-10-13NoNoCurrent
68788-4040-46878840400440 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-4) 2025-10-13NoNoCurrent
68788-4040-56878840400515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-5) 2025-10-13NoNoCurrent
68788-4040-66878840400660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-6) 2025-10-13NoNoCurrent
68788-4040-76878840400750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-7) 2025-10-13NoNoCurrent
68788-4040-868788404008120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-8) 2025-10-13NoNoCurrent
68788-4040-96878840400990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4040-9) 2025-10-13NoNoCurrent