FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
63629-8319
11-digit product format
636298319
Labeler code
63629
Product ID
63629-8319_60f605b4-94c6-4ffe-9b13-ba30fdc6a9b5
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
200 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 HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui833711

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
63629-8319-1TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE3012
63629-8319-2TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE6012
63629-8319-3TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE9012
63629-8319-4TRAMADOL HYDROCHLORIDE120 in 1 BOTTLETABLET, EXTENDED RELEASE12012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8319-1EA - Each63629-8319c9fcb262-596f-4434-8cf8-2ac1222616c312021-01-08
63629-8319-2EA - Each63629-8319bcdaca09-3881-4cdc-a9ca-41d4a882e7e812021-01-08
63629-8319-3EA - Each63629-831928c666da-4b12-4b61-8c03-9156289a144712021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8319TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]12Current NDC, Legacy NDC, 4 package rows20240830_b2f3f007-6dda-4532-9f7f-d93f6e65254c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSNb2f3f007-6dda-4532-9f7f-d93f6e65254c12
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDb2f3f007-6dda-4532-9f7f-d93f6e65254c12
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSYb2f3f007-6dda-4532-9f7f-d93f6e65254c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8319-16362983190130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8319-1) 2020-06-040000-00-00NoNoCurrent
63629-8319-26362983190260 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8319-2) 2020-05-140000-00-00NoNoCurrent
63629-8319-36362983190390 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8319-3) 2020-12-030000-00-00NoNoCurrent
63629-8319-463629831904120 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8319-4) 2024-04-030000-00-00NoNoCurrent