Phentermine and Topiramate Extended-Release

Product NDC: 43598-627
11-digit product format: 435980627
Labeler code: 43598
Product ID: 43598-627_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: 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	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.

Application-product, TE code table
Application-product	TE code
A208175-001	AB
A208175-002	AB
A208175-003	AB
A208175-004	AB

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208175-001	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2025-06-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208175-002	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2025-06-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208175-003	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2025-06-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208175-004	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2025-06-12	`84e616aacf4f…`
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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208175-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208175-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208175-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208175-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208175-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208175-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208175-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208175-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208175-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208175-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208175-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208175-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208175-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208175-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208175-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208175-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208175-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208175-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208175-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208175-004	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208175-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208175-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208175-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208175-004	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	15 mg/1
TOPIRAMATE	92 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0K2I505OTV	Internal UNII lookup
0H73WJJ391	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
260c3f90-163d-0bdd-1099-55d18a900e68	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e5b1b0ba-27f8-4d5d-8943-8aed080fdedc	Product name	4	20260306
6c26dd6d-01b5-4a80-b096-b3a6f7ca6077	Product name	2	20250623
cb966f54-bbf0-40fb-b581-80c6648d510c	Product name	4	20250623
6e2fb0d7-40d7-e97c-1375-fa022ff20193	Product name	4	20250305
3d272a3f-17c0-421d-bc43-3cbdb719258d	Product name	1	20250303
32c2b0bd-1f13-4890-99e0-dcd2ea16e1ab	Product name	2	20230717
ebeae3eb-385d-62da-8827-5ffa80b14e90	Product name	2	20170810
1d682039-1122-1cb7-f3f4-c0a028b98748	Product name	4	20170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56	Product name	3	20161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43598-627-30	Phentermine and Topiramate Extended-Release	30 in 1 BOTTLE	CAPSULE	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-627-30	EA - Each	43598-627	cfa1e328-3dc5-472f-9ab4-3609ca85ae08	1	2025-07-08

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine and Topiramate Extended-Release	PHENTERMINE AND TOPIRAMATE EXTENDED-RELEASE	Dr.Reddys Laboratories Inc	260c3f90-163d-0bdd-1099-55d18a900e68	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208175 application number: ANDA208175 ndc (product): 43598-627

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0K2I505OTV	PHENTERMINE HYDROCHLORIDE	1197-21-3	PHENTERMINE HYDROCHLORIDE
0H73WJJ391	TOPIRAMATE	97240-79-4	TOPIRAMATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1313059	phentermine 11.25 MG / topiramate 69 MG 24HR Extended Release Oral Capsule	PSN	260c3f90-163d-0bdd-1099-55d18a900e68	9
1302850	phentermine 15 MG / topiramate 92 MG 24HR Extended Release Oral Capsule	PSN	260c3f90-163d-0bdd-1099-55d18a900e68	9
1302839	phentermine 3.75 MG / topiramate 23 MG 24HR Extended Release Oral Capsule	PSN	260c3f90-163d-0bdd-1099-55d18a900e68	9
1302827	phentermine 7.5 MG / topiramate 46 MG 24HR Extended Release Oral Capsule	PSN	260c3f90-163d-0bdd-1099-55d18a900e68	9
1313059	24 HR phentermine 11.25 MG / topiramate 69 MG Extended Release Oral Capsule	SCD	260c3f90-163d-0bdd-1099-55d18a900e68	9
1302850	24 HR phentermine 15 MG / topiramate 92 MG Extended Release Oral Capsule	SCD	260c3f90-163d-0bdd-1099-55d18a900e68	9
1302839	24 HR phentermine 3.75 MG / topiramate 23 MG Extended Release Oral Capsule	SCD	260c3f90-163d-0bdd-1099-55d18a900e68	9
1302827	24 HR phentermine 7.5 MG / topiramate 46 MG Extended Release Oral Capsule	SCD	260c3f90-163d-0bdd-1099-55d18a900e68	9
1313059	phentermine 11.25 MG / topiramate 69 MG 24 HR Extended Release Oral Capsule	SY	260c3f90-163d-0bdd-1099-55d18a900e68	9
1302850	phentermine 15 MG / topiramate 92 MG 24 HR Extended Release Oral Capsule	SY	260c3f90-163d-0bdd-1099-55d18a900e68	9
1302839	phentermine 3.75 MG / topiramate 23 MG 24 HR Extended Release Oral Capsule	SY	260c3f90-163d-0bdd-1099-55d18a900e68	9
1302827	phentermine 7.5 MG / topiramate 46 MG 24 HR Extended Release Oral Capsule	SY	260c3f90-163d-0bdd-1099-55d18a900e68	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
43598-627-30	43598062730	30 CAPSULE in 1 BOTTLE (43598-627-30)	30 capsule	2025-06-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phentermine and Topiramate Extended-Release	Dr.Reddys Laboratories Inc \| Dr. Reddys Laboratories Limited (FTO-3)	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	9