FDA.reportPublic FDA data

CITRUCEL

Product NDC
0135-0090
11-digit product format
001350090
Labeler code
0135
Product ID
0135-0090_4d50ac6b-2405-defb-e063-6394a90aa71c
Type
HUMAN OTC DRUG
Nonproprietary name
methylcellulose
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-09-16
Substance
METHYLCELLULOSE (4000 MPA.S)
Active strength
2 g/10.2g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CITRUCEL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLCELLULOSE (4000 MPA.S)2 g/10.2g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMRJ667KA5E
Rxcui1868843, 1868847

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0090-702020-11-17C16284748780-1ab0e2407-27e8-f274-e053-dbdaa90a6471Drug Facts
0135-0090-742020-11-17C16284748780-1ab0e2407-27e8-f274-e053-dbdaa90a6471Drug Facts
0135-0090-752020-11-17C16284748780-1ab0e2407-27e8-f274-e053-dbdaa90a6471Drug Facts
0135-0090-702020-09-27C16284748780-1ab0e2407-27e8-f274-e053-dbdaa90a6471Drug Facts
0135-0090-742020-09-27C16284748780-1ab0e2407-27e8-f274-e053-dbdaa90a6471Drug Facts
0135-0090-752020-09-27C16284748780-1ab0e2407-27e8-f274-e053-dbdaa90a6471Drug Facts
0135-0090-702020-09-25C16284748780-1ab0e2407-27e8-f274-e053-dbdaa90a6471Drug Facts
0135-0090-742020-09-25C16284748780-1ab0e2407-27e8-f274-e053-dbdaa90a6471Drug Facts
0135-0090-752020-09-25C16284748780-1ab0e2407-27e8-f274-e053-dbdaa90a6471Drug Facts
0135-0090-702020-07-22C16284748780-1ab0e2407-27e8-f274-e053-dbdaa90a6471Drug Facts
0135-0090-742020-07-22C16284748780-1ab0e2407-27e8-f274-e053-dbdaa90a6471Drug Facts
0135-0090-752020-07-22C16284748780-1ab0e2407-27e8-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0090-70CITRUCEL479 g in 1 BOTTLEPOWDER, FOR SOLUTION47917
0135-0090-74CITRUCEL907 g in 1 BOTTLEPOWDER, FOR SOLUTION90717
0135-0090-75CITRUCEL1191 g in 1 BOTTLEPOWDER, FOR SOLUTION119117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0090-70GM - Gram0135-009000853d31-b9bc-4a2b-83fa-34968738e49d12013-02-13
0135-0090-74GM - Gram0135-00906393c8cb-0a1f-4f38-858b-174c8c8a36d512012-07-24
0135-0090-75GM - Gram0135-009073c4e040-c8cb-4aaa-a5d7-dd14cf81a71512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLCELLULOSE (4000 MPA.S)ACTIVE INGREDIENTMRJ667KA5ECITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
METHYLCELLULOSE (4000 MPA.S)ACTIVE MOIETYMRJ667KA5ECITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1CITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPCITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFCITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
RIBOFLAVININACTIVE INGREDIENTTLM2976OFRCITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
SUCROSEINACTIVE INGREDIENTC151H8M554CITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP666CITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0090CITRUCEL (METHYLCELLULOSE) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC]16Current NDC, Legacy NDC, 3 package rows20240612_9d5f2244-a610-4d45-b6e8-e79bb17a558f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868847CITRUCEL 2 GM Powder for Oral SuspensionPSN9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868843methylcellulose 2 GM Powder for Oral SuspensionPSN9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868847methylcellulose 2000 MG Powder for Oral Suspension [Citrucel]SBD9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868843methylcellulose 2000 MG Powder for Oral SuspensionSCD9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868847Citrucel 2 GM Granules for Oral SuspensionSY9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868847Citrucel 2 GM Powder for Oral SuspensionSY9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868847Citrucel 2000 MG Powder for Oral SuspensionSY9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868843methylcellulose 2 GM Granules for Oral SuspensionSY9d5f2244-a610-4d45-b6e8-e79bb17a558f17
1868843methylcellulose 2 GM Powder for Oral SuspensionSY9d5f2244-a610-4d45-b6e8-e79bb17a558f17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0090-7000135009070479 g in 1 BOTTLE (0135-0090-70) 479 g2010-09-160000-00-00NoNoCurrent
0135-0090-7400135009074907 g in 1 BOTTLE (0135-0090-74) 907 g2010-09-160000-00-00NoNoCurrent
0135-0090-75001350090751191 g in 1 BOTTLE (0135-0090-75) 1191 g2010-09-162026-05-31NoNoCurrent