FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
71335-9670
11-digit product format
713359670
Labeler code
71335
Product ID
71335-9670_e0a37ad2-9bb4-4c7c-9fc6-24b0fc7f836f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200503
Marketing category
ANDA
Marketing start
2014-08-19
Substance
TRAMADOL HYDROCHLORIDE
Active strength
300 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 HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui833713

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
71335-9670-1TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE30104
71335-9670-2TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE60104
71335-9670-3TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE90104
71335-9670-4TRAMADOL HYDROCHLORIDE120 in 1 BOTTLETABLET, EXTENDED RELEASE120104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9670-1EA - Each71335-96704d21fa4d-7d20-476e-96ff-3bc0176e01d312025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9670TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, 4 package rows20240830_acd5d8e0-a4cc-4654-ae04-faff347a60ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSNacd5d8e0-a4cc-4654-ae04-faff347a60ca104
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCDacd5d8e0-a4cc-4654-ae04-faff347a60ca104
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSYacd5d8e0-a4cc-4654-ae04-faff347a60ca104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9670-17133596700130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9670-1) 2023-03-24NoNoHistorical
71335-9670-27133596700260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9670-2) 2026-04-13NoNoHistorical
71335-9670-37133596700390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9670-3) 2026-01-06NoNoHistorical
71335-9670-471335967004120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9670-4) 2026-04-13NoNoHistorical