FDA.reportPublic FDA data

Qsymia

Product NDC
62541-204
11-digit product format
625410204
Labeler code
62541
Product ID
62541-204_5010eb88-287a-9597-e063-6394a90aad40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine and topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Vivus LLC
Application
NDA022580
Marketing category
NDA
Marketing start
2012-09-17
Substance
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Active strength
15; 92 mg/1; mg/1
Pharmacologic classes
Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE15 mg/1
TOPIRAMATE92 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV, 0H73WJJ391
Rxcui1302827, 1302833, 1302839, 1302845, 1302850, 1302856, 1313059, 1313061

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5b1b0ba-27f8-4d5d-8943-8aed080fdedcProduct name420260306
6c26dd6d-01b5-4a80-b096-b3a6f7ca6077Product name220250623
cb966f54-bbf0-40fb-b581-80c6648d510cProduct name420250623
6e2fb0d7-40d7-e97c-1375-fa022ff20193Product name420250305
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
32c2b0bd-1f13-4890-99e0-dcd2ea16e1abProduct name220230717
ebeae3eb-385d-62da-8827-5ffa80b14e90Product name220170810
1d682039-1122-1cb7-f3f4-c0a028b98748Product name420170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56Product name320161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62541-204-30Qsymia30 in 1 BOTTLE, UNIT-DOSECAPSULE, EXTENDED RELEASE3042

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62541-204-30EA - Each62541-204b2352d85-d636-4bf7-bb2b-c63aa15bf6ab12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
phentermine hydrochlorideACTIVE INGREDIENT0K2I505OTVQSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
topiramateACTIVE INGREDIENT0H73WJJ391QSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
phentermineACTIVE MOIETYC045TQL4WPQSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
topiramateACTIVE MOIETY0H73WJJ391QSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UQSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BQSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDQSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
FD&C Red No. 3INACTIVE INGREDIENTPN2ZH5LOQYQSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MQSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8QSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
gelatinINACTIVE INGREDIENT2G86QN327LQSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
povidone K30INACTIVE INGREDIENTU725QWY32XQSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
starch, cornINACTIVE INGREDIENTO8232NY3SJQSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
sucroseINACTIVE INGREDIENTC151H8M554QSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
talcINACTIVE INGREDIENT7SEV7J4R1UQSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPQSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62541-204QSYMIA (PHENTERMINE AND TOPIRAMATE) CAPSULE, EXTENDED RELEASE [VIVUS LLC]39Current NDC, Legacy NDC, 1 package rows20241004_40dd5602-53da-45ac-bb4b-15789aba40f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1313059phentermine 11.25 MG / topiramate 69 MG 24HR Extended Release Oral CapsulePSN40dd5602-53da-45ac-bb4b-15789aba40f942
1302850phentermine 15 MG / topiramate 92 MG 24HR Extended Release Oral CapsulePSN40dd5602-53da-45ac-bb4b-15789aba40f942
1302839phentermine 3.75 MG / topiramate 23 MG 24HR Extended Release Oral CapsulePSN40dd5602-53da-45ac-bb4b-15789aba40f942
1302827phentermine 7.5 MG / topiramate 46 MG 24HR Extended Release Oral CapsulePSN40dd5602-53da-45ac-bb4b-15789aba40f942
1313061Qsymia 11.25 MG / 69 MG 24HR Extended Release Oral CapsulePSN40dd5602-53da-45ac-bb4b-15789aba40f942
1302856Qsymia 15 MG / 92 MG 24HR Extended Release Oral CapsulePSN40dd5602-53da-45ac-bb4b-15789aba40f942
1302845Qsymia 3.75 MG / 23 MG 24HR Extended Release Oral CapsulePSN40dd5602-53da-45ac-bb4b-15789aba40f942
1302833Qsymia 7.5 MG / 46 MG 24HR Extended Release Oral CapsulePSN40dd5602-53da-45ac-bb4b-15789aba40f942
131306124 HR phentermine 11.25 MG / topiramate 69 MG Extended Release Oral Capsule [Qsymia]SBD40dd5602-53da-45ac-bb4b-15789aba40f942
130285624 HR phentermine 15 MG / topiramate 92 MG Extended Release Oral Capsule [Qsymia]SBD40dd5602-53da-45ac-bb4b-15789aba40f942
130284524 HR phentermine 3.75 MG / topiramate 23 MG Extended Release Oral Capsule [Qsymia]SBD40dd5602-53da-45ac-bb4b-15789aba40f942
130283324 HR phentermine 7.5 MG / topiramate 46 MG Extended Release Oral Capsule [Qsymia]SBD40dd5602-53da-45ac-bb4b-15789aba40f942
131305924 HR phentermine 11.25 MG / topiramate 69 MG Extended Release Oral CapsuleSCD40dd5602-53da-45ac-bb4b-15789aba40f942
130285024 HR phentermine 15 MG / topiramate 92 MG Extended Release Oral CapsuleSCD40dd5602-53da-45ac-bb4b-15789aba40f942
130283924 HR phentermine 3.75 MG / topiramate 23 MG Extended Release Oral CapsuleSCD40dd5602-53da-45ac-bb4b-15789aba40f942
130282724 HR phentermine 7.5 MG / topiramate 46 MG Extended Release Oral CapsuleSCD40dd5602-53da-45ac-bb4b-15789aba40f942
1313059phentermine 11.25 MG / topiramate 69 MG 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1302850phentermine 15 MG / topiramate 92 MG 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1302839phentermine 3.75 MG / topiramate 23 MG 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1302827phentermine 7.5 MG / topiramate 46 MG 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1313061Qsymia 11.25/69 (phentermine (as hydrochloride) / topiramate) 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1313061Qsymia 11.25/69 (phentermine / topiramate) 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1313061Qsymia 11.25/69 (phentermine 11.25 MG / topiramate 69 MG) 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1313061Qsymia 11.25/69 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1302856Qsymia 15/92 (phentermine (as hydrochloride) / topiramate) 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1302856Qsymia 15/92 (phentermine / topiramate) 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1302856Qsymia 15/92 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1302845Qsymia 3.75/23 (phentermine (as hydrochloride) / topiramate) 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1302845Qsymia 3.75/23 (phentermine / topiramate) 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1302845Qsymia 3.75/23 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1302833Qsymia 7.5/46 (phentermine (as hydrochloride) / topiramate) 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1302833Qsymia 7.5/46 (phentermine / topiramate) 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942
1302833Qsymia 7.5/46 24 HR Extended Release Oral CapsuleSY40dd5602-53da-45ac-bb4b-15789aba40f942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62541-204-306254102043030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-204-30) 2012-09-170000-00-00NoNoCurrent