FDA.reportPublic FDA data

Phentermine and topiramate

Product NDC
0480-3297
11-digit product format
004803297
Labeler code
0480
Product ID
0480-3297_b7171ee3-1d6e-4cd9-b72c-426268d38304
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine and topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA204982
Marketing category
ANDA
Marketing start
2025-05-07
Substance
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Active strength
3.75; 23 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
Phentermine and topiramate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE3.75 mg/1
TOPIRAMATE23 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV, 0H73WJJ391
Rxcui1302827, 1302839, 1302850, 1313059

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
0480-3297-56Phentermine and topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-3297-56EA - Each0480-3297dee0064c-97eb-4970-8fba-91eee52f738812025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-3297PHENTERMINE AND TOPIRAMATE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS, INC.]3Current NDC, 1 package rows20250523_918df93d-e033-4419-adcc-e21655ef8158.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1313059phentermine 11.25 MG / topiramate 69 MG 24HR Extended Release Oral CapsulePSN918df93d-e033-4419-adcc-e21655ef81586
1302850phentermine 15 MG / topiramate 92 MG 24HR Extended Release Oral CapsulePSN918df93d-e033-4419-adcc-e21655ef81586
1302839phentermine 3.75 MG / topiramate 23 MG 24HR Extended Release Oral CapsulePSN918df93d-e033-4419-adcc-e21655ef81586
1302827phentermine 7.5 MG / topiramate 46 MG 24HR Extended Release Oral CapsulePSN918df93d-e033-4419-adcc-e21655ef81586
131305924 HR phentermine 11.25 MG / topiramate 69 MG Extended Release Oral CapsuleSCD918df93d-e033-4419-adcc-e21655ef81586
130285024 HR phentermine 15 MG / topiramate 92 MG Extended Release Oral CapsuleSCD918df93d-e033-4419-adcc-e21655ef81586
130283924 HR phentermine 3.75 MG / topiramate 23 MG Extended Release Oral CapsuleSCD918df93d-e033-4419-adcc-e21655ef81586
130282724 HR phentermine 7.5 MG / topiramate 46 MG Extended Release Oral CapsuleSCD918df93d-e033-4419-adcc-e21655ef81586
1313059phentermine 11.25 MG / topiramate 69 MG 24 HR Extended Release Oral CapsuleSY918df93d-e033-4419-adcc-e21655ef81586
1302850phentermine 15 MG / topiramate 92 MG 24 HR Extended Release Oral CapsuleSY918df93d-e033-4419-adcc-e21655ef81586
1302839phentermine 3.75 MG / topiramate 23 MG 24 HR Extended Release Oral CapsuleSY918df93d-e033-4419-adcc-e21655ef81586
1302827phentermine 7.5 MG / topiramate 46 MG 24 HR Extended Release Oral CapsuleSY918df93d-e033-4419-adcc-e21655ef81586

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0480-3297-560048032975630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3297-56) 2025-05-07NoNoHistorical