FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
60760-727
11-digit product format
607600727
Labeler code
60760
Product ID
60760-727_4b9860c4-208c-30bc-e063-6294a90a5b71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA075968
Marketing category
ANDA
Marketing start
2024-08-05
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
60760-727-09Tramadol Hydrochloride9 in 1 BOTTLE, PLASTICTABLET96
60760-727-20Tramadol Hydrochloride20 in 1 BOTTLE, PLASTICTABLET206
60760-727-30Tramadol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET306
60760-727-50Tramadol Hydrochloride50 in 1 BOTTLE, PLASTICTABLET506
60760-727-60Tramadol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET606
60760-727-90Tramadol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET906
60760-727-92Tramadol Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1206
60760-727-98Tramadol Hydrochloride180 in 1 BOTTLE, PLASTICTABLET1806

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-727-09EA - Each60760-727a6fc2dfc-c9df-4991-bdbe-00a1aaa1c97f12026-04-20
60760-727-20EA - Each60760-72721a04ef5-684f-4897-ac72-16b106a4bdae12026-01-08
60760-727-30EA - Each60760-72762001fcd-0de8-4862-b53b-d916cd6368ae12025-12-16
60760-727-50EA - Each60760-72721e11d0d-7c50-4833-b80b-ba2e14ae6de612025-12-16
60760-727-60EA - Each60760-727b55aa5f9-14d0-4ada-97bb-c6ee7885056b12026-02-05
60760-727-90EA - Each60760-72752158c91-16ae-4952-a353-64d9ca40114512025-12-16
60760-727-92EA - Each60760-72715f526ba-2d19-4e0f-8897-feef7df94c8b12026-03-17
60760-727-98EA - Each60760-727c633b95d-bcec-4152-97bf-e4db75ae20bc12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN42de8c3a-0441-5d46-e063-6294a90a20796
835603tramadol hydrochloride 50 MG Oral TabletSCD42de8c3a-0441-5d46-e063-6294a90a20796

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-727-09607600727099 TABLET in 1 BOTTLE, PLASTIC (60760-727-09) 9 tablet2026-02-23NoNoCurrent
60760-727-206076007272020 TABLET in 1 BOTTLE, PLASTIC (60760-727-20) 20 tablet2025-11-13NoNoCurrent
60760-727-306076007273030 TABLET in 1 BOTTLE, PLASTIC (60760-727-30) 30 tablet2025-11-05NoNoCurrent
60760-727-506076007275050 TABLET in 1 BOTTLE, PLASTIC (60760-727-50) 50 tablet2025-11-05NoNoCurrent
60760-727-606076007276060 TABLET in 1 BOTTLE, PLASTIC (60760-727-60) 60 tablet2025-12-29NoNoCurrent
60760-727-906076007279090 TABLET in 1 BOTTLE, PLASTIC (60760-727-90) 90 tablet2025-11-05NoNoCurrent
60760-727-9260760072792120 TABLET in 1 BOTTLE, PLASTIC (60760-727-92) 120 tablet2026-02-16NoNoCurrent
60760-727-9860760072798180 TABLET in 1 BOTTLE, PLASTIC (60760-727-98) 180 tablet2026-02-16NoNoCurrent