FDA.reportPublic FDA data

Tramapap

Manufacturer
Living Well Pharmacy, Inc. | Letco | Spectrum Laboratory Products, Inc. | Medisca
Effective date
2010-05-25
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:09:21

Label at a glance#

ProductTramapap
Active ingredientTramadol Hydrochloride, Acetaminophen
Label structure12 sections

Storage and handling

Prior to compounding, store Tramapap Kit at room temperature. Store the final product at room temperature.

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LWP

381 Van Ness Ave. Suite 1507

Torrance CA, 90501

S/N: LWP304326                              3/29/2010                     LWP,MD

ACETAMINOPHEN GRANULAR, USP #75 GM

BATCH: 03292010Z                                                            HEALTH: 1

MFG: LIVING WELL PHARMACY                                        FIRE: 1

NDC: 64038-0135-75                                                           REACTIVITY: 0

CAS #: 103-90-2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Acetaminophen.Granular.USP.label
Acetaminophen.Granular.USP.label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LWP

381 Van Ness Ave. Suite 1507

Torrance CA, 90501

S/N: LWP307039                              4/6/2010                     LWP,MD

TRAMADOL HCL #15GM

BATCH: 04062010Z                                                            HEALTH: 2

MFG: LIVING WELL PHARMACY                                        FIRE: 1

NDC: 64038-0738-15                                                           REACTIVITY: 0

CAS #: 73806-49-2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tramadol 15 GM
Tramadol 15 GM

DESCRIPTION SECTION

  1. RX Only

For Prescription Compounding Only


Tramapap Kit
Tramadol HCl and Acetaminophen Compound Kit

Description

Each Tramapap Kit is comprised of 15 grams of tramadol hydrochloride powder and  75 grams of acetaminophen powder.

Certificate of Analysis on File

Tramapap Kit also contains 23.25 grams of Lactose Monohydrate (Spray dried) powder and 1.5 grams of
riboflavin USP powder. When compounded, the final product provides a homogeneous product of 300
capsules each capsule containing 50mg of tramadol and 250mg of acetaminophen.

INDICATIONS & USAGE SECTION

Equipment

Required supplies needed to compound this kit


Equipment
Item
Quantity
Tramadol HCl (Included)
15 grams
Acetaminophen (Included)
75 grams
Lactose Monohydrate Spray Dried Powder ( Included)
23.25 grams
Riboflavin Powder (Included)
1.5 grams
Red/Blue #1 Capsules ( Required Not Included)
300 Capsules




DRUG & OR LABORATORY TEST INTERACTIONS SECTION

Equipment

Recommended supplies not included in this kit

Equipment
Item
Quantity
16 oz Glass Mortar and Pestle
1 each
300 Capsule Machine Number 2 Notch
1
Scraper ( Recommended Not Included)
1
Tamper (Recommended Not Included)
1
Capsule Locker (Recommended Not Included)
1


DOSAGE & ADMINISTRATION SECTION

Directions

1. Using a 16 oz mortar and pestle triturate powders well to reduce particle size until uniform.

2. Using a 300 capsule machine encapsulate triturate powder mixture into number 1 red/blue capsules

STORAGE AND HANDLING SECTION

Prior to compounding, store Tramapap Kit at room temperature. Store the final product at room temperature.

WARNINGS AND PRECAUTIONS SECTION

Final product for oral use only. Keep out the reach of children. Compounded product, as dispensed,

is stable for at least 180 days or the time remaining on the expiration date of any given ingredient,

which ever is shorter.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Directions
Directions

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tramapapuse
tramapapuse

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
999729traMADol HCl 50 MG / acetaminophen 250 MG Oral CapsulePSN3
999729acetaminophen 250 MG / tramadol hydrochloride 50 MG Oral CapsuleSCD3
999729APAP 250 MG / tramadol hydrochloride 50 MG Oral CapsuleSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TRAMADOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
64038-059-032019-10-21C16284748780-1956f9ecf-c6ba-621f-e053-dbdaa90a74adTramapap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64038-059-03Tramapap1 in 1 KITKIT13
64038-135-75Tramapap75 g in 1 BOTTLEPOWDER75 g1 g in 1g3
64038-738-15Tramapap15 g in 1 BOTTLEPOWDER15 g1 g in 1g3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64038-059TRAMAPAP (TRAMADOL HYDROCHLORIDE, ACETAMINOPHEN) KIT [LIVING WELL PHARMACY, INC.]3Legacy NDC, 3 package rows20100719_e142844d-a0f3-4b33-a3ca-795456bafa1a.zip
64038-135TRAMAPAP (TRAMADOL HYDROCHLORIDE, ACETAMINOPHEN) KIT [LIVING WELL PHARMACY, INC.]3Unmatched20100719_e142844d-a0f3-4b33-a3ca-795456bafa1a.zip
64038-738TRAMAPAP (TRAMADOL HYDROCHLORIDE, ACETAMINOPHEN) KIT [LIVING WELL PHARMACY, INC.]3Unmatched20100719_e142844d-a0f3-4b33-a3ca-795456bafa1a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D3
Tramadol HydrochlorideACTIVE INGREDIENT9N7R477WCK3
AcetaminophenACTIVE MOIETY362O9ITL9D3
TramadolACTIVE MOIETY39J1LGJ30J3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64038-05964038-059-03
64038-73864038-738-15
64038-13564038-135-75

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Tramadol Hydrochloride9N7R477WCKACTIB
Acetaminophen362O9ITL9DACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
67469a82-09e3-4671-9776-f72ee54004bfe142844d-a0f3-4b33-a3ca-795456bafa1a2010-05-25WarningsExact identifier
spl id: 67469a82-09e3-4671-9776-f72ee54004bf
spl set id: e142844d-a0f3-4b33-a3ca-795456bafa1a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.