FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
71205-740
11-digit product format
712050740
Labeler code
71205
Product ID
71205-740_39d70777-2751-4f9e-a26b-675027a634c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203494
Marketing category
ANDA
Marketing start
2020-09-23
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
71205-740-15Tramadol Hydrochloride15 in 1 BOTTLETABLET, FILM COATED156
71205-740-20Tramadol Hydrochloride20 in 1 BOTTLETABLET, FILM COATED206
71205-740-30Tramadol Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
71205-740-40Tramadol Hydrochloride40 in 1 BOTTLETABLET, FILM COATED406
71205-740-60Tramadol Hydrochloride60 in 1 BOTTLETABLET, FILM COATED606
71205-740-72Tramadol Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1206
71205-740-78Tramadol Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1806
71205-740-90Tramadol Hydrochloride90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-740-15EA - Each71205-740b747709f-67c6-4965-ae1b-58fcb639ad4512024-02-14
71205-740-20EA - Each71205-740a7ef1c40-e251-4cf0-b9d4-a828684b0bd712024-06-10
71205-740-40EA - Each71205-74053b51167-5408-41b1-b33b-5b180851fcea12024-04-05
71205-740-60EA - Each71205-740df40a0bc-a19c-4c39-8127-4b0e1d742ca912024-01-04
71205-740-72EA - Each71205-740414f13e2-ca47-434f-9fe5-fd8f7a6366b112024-06-10
71205-740-78EA - Each71205-740384c2c91-5830-4a44-8c83-0731b85c3d3a12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-740TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, 8 package rows20240412_e90d4ef3-8b90-41b7-bf96-340852e89b5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNe90d4ef3-8b90-41b7-bf96-340852e89b5f6
835603tramadol hydrochloride 50 MG Oral TabletSCDe90d4ef3-8b90-41b7-bf96-340852e89b5f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-740-157120507401515 TABLET, FILM COATED in 1 BOTTLE (71205-740-15) 2023-12-12NoNoCurrent
71205-740-207120507402020 TABLET, FILM COATED in 1 BOTTLE (71205-740-20) 2024-03-12NoNoCurrent
71205-740-307120507403030 TABLET, FILM COATED in 1 BOTTLE (71205-740-30) 2023-09-19NoNoCurrent
71205-740-407120507404040 TABLET, FILM COATED in 1 BOTTLE (71205-740-40) 2024-02-07NoNoCurrent
71205-740-607120507406060 TABLET, FILM COATED in 1 BOTTLE (71205-740-60) 2023-09-19NoNoCurrent
71205-740-7271205074072120 TABLET, FILM COATED in 1 BOTTLE (71205-740-72) 2024-04-08NoNoCurrent
71205-740-7871205074078180 TABLET, FILM COATED in 1 BOTTLE (71205-740-78) 2023-10-20NoNoCurrent
71205-740-907120507409090 TABLET, FILM COATED in 1 BOTTLE (71205-740-90) 2023-09-19NoNoCurrent