Home NDC 43598-624 Phentermine and Topiramate Extended-Release
Product NDC 43598-624
11-digit product format 435980624
Labeler code 43598
Product ID 43598-624_ce37425a-12f1-722f-ab5b-d95615c635a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentermine and Topiramate Extended-Release
Dosage form CAPSULE
Route ORAL
Labeler Dr.Reddys Laboratories Inc
Application ANDA208175
Marketing category ANDA
Marketing start 2025-06-12
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208175-001 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE PHENTERMINE HYDROCHLORIDE; TOPIRAMATE EQ 3.75MG BASE;23MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 A208175-002 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE PHENTERMINE HYDROCHLORIDE; TOPIRAMATE EQ 7.5MG BASE;46MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 A208175-003 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE PHENTERMINE HYDROCHLORIDE; TOPIRAMATE EQ 11.25MG BASE;69MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 A208175-004 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE PHENTERMINE HYDROCHLORIDE; TOPIRAMATE EQ 15MG BASE;92MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A208175-001 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 3.75MG BASE;23MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208175-002 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 7.5MG BASE;46MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208175-003 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 11.25MG BASE;69MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208175-004 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 15MG BASE;92MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208175-001 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 3.75MG BASE;23MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208175-002 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 7.5MG BASE;46MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208175-003 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 11.25MG BASE;69MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208175-004 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 15MG BASE;92MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208175-001 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 3.75MG BASE;23MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208175-002 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 7.5MG BASE;46MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208175-003 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 11.25MG BASE;69MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208175-004 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 15MG BASE;92MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208175-001 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 3.75MG BASE;23MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208175-002 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 7.5MG BASE;46MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208175-003 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 11.25MG BASE;69MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208175-004 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 15MG BASE;92MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208175-001 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 3.75MG BASE;23MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208175-002 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 7.5MG BASE;46MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208175-003 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 11.25MG BASE;69MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208175-004 PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE EQ 15MG BASE;92MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-06-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Phentermine and Topiramate Extended-Release
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENTERMINE HYDROCHLORIDE 3.75 mg/1 TOPIRAMATE 23 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0H73WJJ391 Internal UNII lookup 0K2I505OTV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1302827 Internal RxNorm lookup 1302839 Internal RxNorm lookup 1302850 Internal RxNorm lookup 1313059 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43598-624-30 Phentermine and Topiramate Extended-Release 30 in 1 BOTTLE CAPSULE 30 9
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43598-624-30 43598062430 30 CAPSULE in 1 BOTTLE (43598-624-30) 30 capsule 2025-06-12 No No Current