FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
71335-9658
11-digit product format
713359658
Labeler code
71335
Product ID
71335-9658_7153f206-8ea3-4cc7-9ce3-733bc1712d2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208708
Marketing category
ANDA
Marketing start
2023-07-24
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
71335-9658-0Tramadol Hydrochloride50 in 1 BOTTLETABLET, COATED50104
71335-9658-1Tramadol Hydrochloride30 in 1 BOTTLETABLET, COATED30104
71335-9658-2Tramadol Hydrochloride20 in 1 BOTTLETABLET, COATED20104
71335-9658-3Tramadol Hydrochloride90 in 1 BOTTLETABLET, COATED90104
71335-9658-4Tramadol Hydrochloride60 in 1 BOTTLETABLET, COATED60104
71335-9658-5Tramadol Hydrochloride120 in 1 BOTTLETABLET, COATED120104
71335-9658-6Tramadol Hydrochloride180 in 1 BOTTLETABLET, COATED180104
71335-9658-7Tramadol Hydrochloride40 in 1 BOTTLETABLET, COATED40104
71335-9658-8Tramadol Hydrochloride100 in 1 BOTTLETABLET, COATED100104
71335-9658-9Tramadol Hydrochloride15 in 1 BOTTLETABLET, COATED15104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9658-1EA - Each71335-9658abff8e31-1edd-4293-bf28-0bd80b3aeaa612025-09-12
71335-9658-3EA - Each71335-96584aa97d37-9792-4b8a-b1c7-02f72b81792c12025-12-16
71335-9658-4EA - Each71335-965843b6a020-3410-43a3-b4ce-4d2f0a36087c12025-07-08
71335-9658-5EA - Each71335-9658d716c6c5-c0a5-44a9-a878-331d5c40a57012025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9658TRAMADOL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]103Current NDC, 10 package rows20241019_674803a0-4cf5-4416-a5e3-c1a1e332cdcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN674803a0-4cf5-4416-a5e3-c1a1e332cdcd104
835603tramadol hydrochloride 50 MG Oral TabletSCD674803a0-4cf5-4416-a5e3-c1a1e332cdcd104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9658-07133596580050 TABLET, COATED in 1 BOTTLE (71335-9658-0) 2026-04-13NoNoHistorical
71335-9658-17133596580130 TABLET, COATED in 1 BOTTLE (71335-9658-1) 2025-06-24NoNoHistorical
71335-9658-27133596580220 TABLET, COATED in 1 BOTTLE (71335-9658-2) 2025-07-02NoNoHistorical
71335-9658-37133596580390 TABLET, COATED in 1 BOTTLE (71335-9658-3) 2025-07-29NoNoHistorical
71335-9658-47133596580460 TABLET, COATED in 1 BOTTLE (71335-9658-4) 2026-04-13NoNoHistorical
71335-9658-571335965805120 TABLET, COATED in 1 BOTTLE (71335-9658-5) 2025-07-15NoNoHistorical
71335-9658-671335965806180 TABLET, COATED in 1 BOTTLE (71335-9658-6) 2026-04-13NoNoHistorical
71335-9658-77133596580740 TABLET, COATED in 1 BOTTLE (71335-9658-7) 2026-04-13NoNoHistorical
71335-9658-871335965808100 TABLET, COATED in 1 BOTTLE (71335-9658-8) 2025-12-24NoNoHistorical
71335-9658-97133596580915 TABLET, COATED in 1 BOTTLE (71335-9658-9) 2026-04-13NoNoHistorical