FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
71610-006
11-digit product format
716100006
Labeler code
71610
Product ID
71610-006_069eec8b-6cca-435c-9d3f-fbdc75a813a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075977
Marketing category
ANDA
Marketing start
2017-08-24
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
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
71610-006-15Tramadol Hydrochloride15 in 1 BOTTLETABLET, FILM COATED153
71610-006-20Tramadol Hydrochloride20 in 1 BOTTLETABLET, FILM COATED203
71610-006-24Tramadol Hydrochloride224 in 1 BOTTLETABLET, FILM COATED2243
71610-006-28Tramadol Hydrochloride28 in 1 BOTTLETABLET, FILM COATED283
71610-006-30Tramadol Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
71610-006-40Tramadol Hydrochloride40 in 1 BOTTLETABLET, FILM COATED403
71610-006-45Tramadol Hydrochloride45 in 1 BOTTLETABLET, FILM COATED453
71610-006-46Tramadol Hydrochloride56 in 1 BOTTLETABLET, FILM COATED563
71610-006-48Tramadol Hydrochloride480 in 1 BOTTLETABLET, FILM COATED4803
71610-006-50Tramadol Hydrochloride50 in 1 BOTTLETABLET, FILM COATED503
71610-006-53Tramadol Hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
71610-006-54Tramadol Hydrochloride84 in 1 BOTTLETABLET, FILM COATED843
71610-006-57Tramadol Hydrochloride80 in 1 BOTTLETABLET, FILM COATED803
71610-006-60Tramadol Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903
71610-006-65Tramadol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1003
71610-006-67Tramadol Hydrochloride168 in 1 BOTTLETABLET, FILM COATED1683
71610-006-70Tramadol Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1203
71610-006-72Tramadol Hydrochloride112 in 1 BOTTLETABLET, FILM COATED1123
71610-006-73Tramadol Hydrochloride135 in 1 BOTTLETABLET, FILM COATED1353
71610-006-75Tramadol Hydrochloride150 in 1 BOTTLETABLET, FILM COATED1503
71610-006-80Tramadol Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1803
71610-006-85Tramadol Hydrochloride200 in 1 BOTTLETABLET, FILM COATED2003
71610-006-89Tramadol Hydrochloride720 in 1 BOTTLETABLET, FILM COATED7203
71610-006-90Tramadol Hydrochloride240 in 1 BOTTLETABLET, FILM COATED2403
71610-006-92Tramadol Hydrochloride270 in 1 BOTTLETABLET, FILM COATED2703
71610-006-94Tramadol Hydrochloride360 in 1 BOTTLETABLET, FILM COATED3603
71610-006-98Tramadol Hydrochloride540 in 1 BOTTLETABLET, FILM COATED5403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-006-15EA - Each71610-0066eae97ff-56b1-4db5-89f1-49d65d8dab2712018-02-20
71610-006-20EA - Each71610-006110b3a81-bef4-491d-a3be-dee77f706fae12018-02-20
71610-006-24EA - Each71610-006cd0990bf-dc13-40c7-9b2d-3266bb0dc75412018-02-20
71610-006-28EA - Each71610-006a0f0e996-1e56-4a51-abfb-d3f3a9a1eb0912018-02-20
71610-006-30EA - Each71610-0068d257b29-fdb0-4668-b1db-e4f34f47643612018-02-20
71610-006-40EA - Each71610-00662bb9ddd-aef4-45f0-a980-f64a881e042212018-02-20
71610-006-45EA - Each71610-0061529ff7f-a78c-41c1-b775-d6751098d8f412018-02-20
71610-006-46EA - Each71610-006a6d25433-46db-4de8-b03c-5eb85fb0dd4812018-02-20
71610-006-48EA - Each71610-006740e1bb4-3d8b-48dd-888c-01fd9ac45c1512018-02-20
71610-006-50EA - Each71610-006a75012f7-fd4f-49af-9914-0a1be014f33b12018-02-20
71610-006-53EA - Each71610-0061d6ff9d6-6724-4cca-b6d5-5ab8cc3e88d612018-02-20
71610-006-54EA - Each71610-006c72c40ff-8038-4cf3-8605-c38a5d86b92a12018-02-20
71610-006-57EA - Each71610-0065963ca2c-8f47-479c-b2ea-fda60568d62612018-02-20
71610-006-60EA - Each71610-0066d21c748-46a9-4d38-9e57-b4fcaa8f2c0012018-02-20
71610-006-65EA - Each71610-0066832ed3d-22f4-42f6-b42d-9933d11b1c9d12018-02-20
71610-006-67EA - Each71610-0063ac6954c-c64b-4bc5-93ec-f243d2fff9a712018-02-20
71610-006-70EA - Each71610-0062fa1a4ed-0475-48a3-9336-7221281b7d2312018-02-20
71610-006-72EA - Each71610-0067e36b9d7-4774-46e0-9790-958c57424eeb12018-02-20
71610-006-73EA - Each71610-0060e6b3fc8-7f1e-46ff-abe9-175d97e4c2fa12018-02-20
71610-006-75EA - Each71610-0065c81c9db-513f-4217-9bb0-043151736ead12018-02-20
71610-006-80EA - Each71610-006f44d0128-5e79-4058-b69e-7eb19314ce2012018-02-20
71610-006-85EA - Each71610-006423af747-2620-4c76-ad1a-192a3066dc7412018-02-20
71610-006-89EA - Each71610-006320507fa-1a2b-423a-969a-dca883c29a2612018-02-20
71610-006-90EA - Each71610-00619127b9e-170c-4c9b-8889-106fc27d908112018-02-20
71610-006-92EA - Each71610-006b172b63f-4dfd-411e-8de2-a0dafaf506a212018-02-20
71610-006-94EA - Each71610-00636621615-2029-46dd-8429-6bdd22c80dcc12018-02-20
71610-006-98EA - Each71610-00684989a9d-9a1d-49ba-bb1c-92c3443388b212018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-006TRAMADOL HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 27 package rows20190424_bbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNbbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e3
835603tramadol hydrochloride 50 MG Oral TabletSCDbbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-006-157161000061515 TABLET, FILM COATED in 1 BOTTLE (71610-006-15) 2017-10-060000-00-00NoNoCurrent
71610-006-207161000062020 TABLET, FILM COATED in 1 BOTTLE (71610-006-20) 2017-10-060000-00-00NoNoCurrent
71610-006-2471610000624224 TABLET, FILM COATED in 1 BOTTLE (71610-006-24) 2017-10-060000-00-00NoNoCurrent
71610-006-287161000062828 TABLET, FILM COATED in 1 BOTTLE (71610-006-28) 2017-10-060000-00-00NoNoCurrent
71610-006-307161000063030 TABLET, FILM COATED in 1 BOTTLE (71610-006-30) 2017-10-060000-00-00NoNoCurrent
71610-006-407161000064040 TABLET, FILM COATED in 1 BOTTLE (71610-006-40) 2017-10-060000-00-00NoNoCurrent
71610-006-457161000064545 TABLET, FILM COATED in 1 BOTTLE (71610-006-45) 2017-10-060000-00-00NoNoCurrent
71610-006-467161000064656 TABLET, FILM COATED in 1 BOTTLE (71610-006-46) 2017-10-060000-00-00NoNoCurrent
71610-006-4871610000648480 TABLET, FILM COATED in 1 BOTTLE (71610-006-48) 2017-10-060000-00-00NoNoCurrent
71610-006-507161000065050 TABLET, FILM COATED in 1 BOTTLE (71610-006-50) 2017-10-060000-00-00NoNoCurrent
71610-006-537161000065360 TABLET, FILM COATED in 1 BOTTLE (71610-006-53) 2017-10-060000-00-00NoNoCurrent
71610-006-547161000065484 TABLET, FILM COATED in 1 BOTTLE (71610-006-54) 2017-10-060000-00-00NoNoCurrent
71610-006-577161000065780 TABLET, FILM COATED in 1 BOTTLE (71610-006-57) 2017-08-240000-00-00NoNoCurrent
71610-006-607161000066090 TABLET, FILM COATED in 1 BOTTLE (71610-006-60) 2017-10-060000-00-00NoNoCurrent
71610-006-6571610000665100 TABLET, FILM COATED in 1 BOTTLE (71610-006-65) 2017-10-060000-00-00NoNoCurrent
71610-006-6771610000667168 TABLET, FILM COATED in 1 BOTTLE (71610-006-67) 2017-10-060000-00-00NoNoCurrent
71610-006-7071610000670120 TABLET, FILM COATED in 1 BOTTLE (71610-006-70) 2017-10-060000-00-00NoNoCurrent
71610-006-7271610000672112 TABLET, FILM COATED in 1 BOTTLE (71610-006-72) 2017-10-060000-00-00NoNoCurrent
71610-006-7371610000673135 TABLET, FILM COATED in 1 BOTTLE (71610-006-73) 2017-10-060000-00-00NoNoCurrent
71610-006-7571610000675150 TABLET, FILM COATED in 1 BOTTLE (71610-006-75) 2017-10-060000-00-00NoNoCurrent
71610-006-8071610000680180 TABLET, FILM COATED in 1 BOTTLE (71610-006-80) 2017-10-060000-00-00NoNoCurrent
71610-006-8571610000685200 TABLET, FILM COATED in 1 BOTTLE (71610-006-85) 2017-10-060000-00-00NoNoCurrent
71610-006-8971610000689720 TABLET, FILM COATED in 1 BOTTLE (71610-006-89) 2017-10-060000-00-00NoNoCurrent
71610-006-9071610000690240 TABLET, FILM COATED in 1 BOTTLE (71610-006-90) 2017-10-060000-00-00NoNoCurrent
71610-006-9271610000692270 TABLET, FILM COATED in 1 BOTTLE (71610-006-92) 2017-10-060000-00-00NoNoCurrent
71610-006-9471610000694360 TABLET, FILM COATED in 1 BOTTLE (71610-006-94) 2017-10-060000-00-00NoNoCurrent
71610-006-9871610000698540 TABLET, FILM COATED in 1 BOTTLE (71610-006-98) 2017-10-060000-00-00NoNoCurrent