Ustell

Product NDC
0076-0903
11-digit product format
000760903
Labeler code
0076
Product ID
0076-0903_45c7c55c-ce7d-1f92-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
Dosage form
CAPSULE
Route
ORAL
Labeler
Star Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-09-27
Marketing end
0000-00-00
Substance
METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE
Active strength
120 mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210
c39b72c3-7732-4ed2-a995-e6aa3a665a54Product name320250819
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0076-0903-012020-01-31C16284748780-19d75b9cf-ecf0-f424-e053-dadaa90a57ceUstell™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0076-0903-01Ustell100 in 1 BOTTLECAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0076-0903-01EA - Each0076-090376430e69-63ae-4c08-8ba9-4240d40dcb8112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hyoscyamine SulfateACTIVE INGREDIENTF2R8V82B84USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
MethenamineACTIVE INGREDIENTJ50OIX95QVUSTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
Methylene BlueACTIVE INGREDIENTT42P99266KUSTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
Phenyl SalicylateACTIVE INGREDIENT28A37T47QOUSTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
Sodium Phosphate, Monobasic, MonohydrateACTIVE INGREDIENT593YOG76RNUSTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
HyoscyamineACTIVE MOIETYPX44XO846XUSTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
MethenamineACTIVE MOIETYJ50OIX95QVUSTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
Methylene BlueACTIVE MOIETYT42P99266KUSTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
Phenyl SalicylateACTIVE MOIETY28A37T47QOUSTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
Sodium CationACTIVE MOIETYLYR4M0NH37USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
AmmoniaINACTIVE INGREDIENT5138Q19F1XUSTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
Anhydrous Dibasic Calcium PhosphateINACTIVE INGREDIENTL11K75P92JUSTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UUSTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
ShellacINACTIVE INGREDIENT46N107B71OUSTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APUSTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPUSTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0076-0903USTELL (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [STAR PHARMACEUTICALS LLC]2Legacy NDC, 1 package rows20170111_dc773b57-378b-4650-9bb0-34e6f8c067ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1048307hyoscyamine sulfate 0.12 MG / methenamine 120 MG / methylene blue 10 MG / phenyl salicylate 36 MG / sodium phosphate, monobasic 40.8 MG Oral CapsulePSNdc773b57-378b-4650-9bb0-34e6f8c067ab2
1101637Ustell 120 MG / 40.8 MG / 36 MG / 10 MG / 0.12 MG Oral CapsulePSNdc773b57-378b-4650-9bb0-34e6f8c067ab2
1101637hyoscyamine sulfate 0.12 MG / methenamine 120 MG / methylene blue 10 MG / phenyl salicylate 36 MG / sodium phosphate, monobasic 40.8 MG Oral Capsule [Ustell]SBDdc773b57-378b-4650-9bb0-34e6f8c067ab2
1048307hyoscyamine sulfate 0.12 MG / methenamine 120 MG / methylene blue 10 MG / phenyl salicylate 36 MG / sodium phosphate, monobasic 40.8 MG Oral CapsuleSCDdc773b57-378b-4650-9bb0-34e6f8c067ab2
1101637Ustell (hyoscyamine sulfate 0.12 MG / methenamine 120 MG / methylene blue 10 MG / phenyl salicylate 36 MG / sodium phosphate, monobasic 40.8 MG) Oral CapsuleSYdc773b57-378b-4650-9bb0-34e6f8c067ab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0076-0903-0100076090301100 in 1 BOTTLEHistorical