FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
52959-688
11-digit product format
529590688
Labeler code
52959
Product ID
52959-688_5d544cbc-94c2-6194-e053-2991aa0ada36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company Inc.
Application
ANDA090404
Marketing category
ANDA
Marketing start
2017-01-03
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-688-002020-01-31C16284748780-19d75b9d0-1753-f424-e053-dadaa90a57ce5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-022020-01-31C16284748780-19d75b9d0-1753-f424-e053-dadaa90a57ce5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-102020-01-31C16284748780-19d75b9d0-1753-f424-e053-dadaa90a57ce5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-152020-01-31C16284748780-19d75b9d0-1753-f424-e053-dadaa90a57ce5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-202020-01-31C16284748780-19d75b9d0-1753-f424-e053-dadaa90a57ce5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-212020-01-31C16284748780-19d75b9d0-1753-f424-e053-dadaa90a57ce5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-282020-01-31C16284748780-19d75b9d0-1753-f424-e053-dadaa90a57ce5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-302020-01-31C16284748780-19d75b9d0-1753-f424-e053-dadaa90a57ce5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-402020-01-31C16284748780-19d75b9d0-1753-f424-e053-dadaa90a57ce5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-502020-01-31C16284748780-19d75b9d0-1753-f424-e053-dadaa90a57ce5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-602020-01-31C16284748780-19d75b9d0-1753-f424-e053-dadaa90a57ce5d544cbc-94c1-6194-e053-2991aa0ada36
52959-688-902020-01-31C16284748780-19d75b9d0-1753-f424-e053-dadaa90a57ce5d544cbc-94c1-6194-e053-2991aa0ada36

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-688-60Theratramadol-9060 in 1 BOTTLETABLET6050 mg22
52959-688-60Theratramadol-6060 in 1 BOTTLETABLET6050 mg3
52959-688-00TRAMADOL HYDROCHLORIDE100 in 1 CONTAINERTABLET1001
52959-688-02TRAMADOL HYDROCHLORIDE120 in 1 CONTAINERTABLET1201
52959-688-10TRAMADOL HYDROCHLORIDE10 in 1 CONTAINERTABLET101
52959-688-15TRAMADOL HYDROCHLORIDE15 in 1 CONTAINERTABLET151
52959-688-20TRAMADOL HYDROCHLORIDE20 in 1 CONTAINERTABLET201
52959-688-21TRAMADOL HYDROCHLORIDE21 in 1 CONTAINERTABLET211
52959-688-28TRAMADOL HYDROCHLORIDE28 in 1 CONTAINERTABLET281
52959-688-30TRAMADOL HYDROCHLORIDE30 in 1 CONTAINERTABLET301
52959-688-40TRAMADOL HYDROCHLORIDE40 in 1 CONTAINERTABLET401
52959-688-50TRAMADOL HYDROCHLORIDE50 in 1 CONTAINERTABLET501
52959-688-60TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET601
52959-688-90TRAMADOL HYDROCHLORIDE90 in 1 CONTAINERTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-688-00EA - Each52959-6887c01630c-13d5-4e4a-a868-7bf91f83fbd412017-12-14
52959-688-02EA - Each52959-68880921bf3-a3c6-493e-b203-ecfe5fe8850412017-12-14
52959-688-10EA - Each52959-6880cb8c36d-73e4-45db-96bf-c972eab5878512017-12-14
52959-688-15EA - Each52959-68810aa5eed-0de7-41df-b73e-9c7941139d3d12017-12-14
52959-688-20EA - Each52959-688e868d378-9a08-4835-94df-f5671af1bcf512017-12-14
52959-688-21EA - Each52959-6886a3421b1-62fb-476b-9100-4a43210bc54612017-12-14
52959-688-28EA - Each52959-688c8167055-5aa9-4abe-a1d9-2503820e1d3b12017-12-14
52959-688-30EA - Each52959-68810cbd269-eb45-4785-8ee3-7c11cce8648f12017-12-14
52959-688-40EA - Each52959-6888e07888c-86d5-48cd-bffb-01ef9c025ea012017-12-14
52959-688-50EA - Each52959-688f105f142-7552-4616-bdef-2ee53620613c12017-12-14
52959-688-60EA - Each52959-6885dbefb3c-a8df-4025-b6e3-7d9243cff78312017-12-14
52959-688-90EA - Each52959-6880262d035-5b69-4be8-a0c6-924c5d55ff7312017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6ITHERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTHERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6ITHERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
TRAMADOLACTIVE MOIETY39J1LGJ30JTHERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTHERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
GELATININACTIVE INGREDIENT2G86QN327LTHERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22
.GAMMA.-AMINOBUTYRIC ACIDACTIVE INGREDIENT2ACZ6IPC6ITHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
.GAMMA.-AMINOBUTYRIC ACIDACTIVE MOIETY2ACZ6IPC6ITHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
TRAMADOLACTIVE MOIETY39J1LGJ30JTHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYTHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
GELATININACTIVE INGREDIENT2G86QN327LTHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MTHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTHERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP666THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-688THERATRAMADOL-90 (TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]22Legacy NDC20110812_b4a17a69-e764-456c-8aa9-d31221c86a6b.zip
52959-688THERATRAMADOL-60 (TRAMADOL HYDROCHLORIDE, GABA) KIT [PHYSICIAN THERAPEUTICS LLC]3Legacy NDC20110812_379f8193-c371-4ae9-a272-43c5b9b18349.zip
52959-688TRAMADOL HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]1Legacy NDC, 12 package rows20171110_5d544cbc-94c1-6194-e053-2991aa0ada36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNb4a17a69-e764-456c-8aa9-d31221c86a6b22
835603tramadol hydrochloride 50 MG Oral TabletSCDb4a17a69-e764-456c-8aa9-d31221c86a6b22
835603traMADol HCl 50 MG Oral TabletPSN379f8193-c371-4ae9-a272-43c5b9b183493
835603tramadol hydrochloride 50 MG Oral TabletSCD379f8193-c371-4ae9-a272-43c5b9b183493
835603traMADol HCl 50 MG Oral TabletPSN5d544cbc-94c1-6194-e053-2991aa0ada361
835603tramadol hydrochloride 50 MG Oral TabletSCD5d544cbc-94c1-6194-e053-2991aa0ada361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-688-0052959068800100 in 1 CONTAINERHistorical
52959-688-0252959068802120 in 1 CONTAINERHistorical
52959-688-105295906881010 in 1 CONTAINERHistorical
52959-688-155295906881515 in 1 CONTAINERHistorical
52959-688-205295906882020 in 1 CONTAINERHistorical
52959-688-215295906882121 in 1 CONTAINERHistorical
52959-688-285295906882828 in 1 CONTAINERHistorical
52959-688-305295906883030 in 1 CONTAINERHistorical
52959-688-405295906884040 in 1 CONTAINERHistorical
52959-688-505295906885050 in 1 CONTAINERHistorical
52959-688-605295906886060 in 1 BOTTLEHistorical
52959-688-905295906889090 in 1 CONTAINERHistorical