phentermine and topiramate

Product NDC: 66993-781
11-digit product format: 669930781
Labeler code: 66993
Product ID: 66993-781_52217277-c719-2f2f-e063-6394a90a6699
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: phentermine and topiramate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Prasco Laboratories
Application: NDA022580
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2025-06-01
Substance: PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Active strength: 7.5; 46 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	RLD / RS	Approval date
N022580-001	QSYMIA	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17
N022580-002	QSYMIA	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17
N022580-003	QSYMIA	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17
N022580-004	QSYMIA	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-07-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022580-001	AB
N022580-002	AB
N022580-003	AB
N022580-004	AB

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022580-001	8895057	2028-06-09	U-3398		2014-12-18
N022580-001	8895058	2028-06-09		Drug product	2014-12-18
N022580-001	9011905	2028-06-09		Drug product	2015-05-13
N022580-001	9011906	2028-06-09	U-3398		2015-05-13
N022580-001	8580298	2029-05-15		Drug product	2013-11-14
N022580-001	8580299	2029-06-14	U-3399		2013-11-14
N022580-002	8895057	2028-06-09	U-3398		2014-12-18
N022580-002	8895058	2028-06-09		Drug product	2014-12-18
N022580-002	9011905	2028-06-09		Drug product	2015-05-13
N022580-002	9011906	2028-06-09	U-3398		2015-05-13
N022580-002	8580298	2029-05-15		Drug product
N022580-002	8580299	2029-06-14	U-3399
N022580-003	8895057	2028-06-09	U-3398		2014-12-18
N022580-003	8895058	2028-06-09		Drug product	2014-12-18
N022580-003	9011905	2028-06-09		Drug product	2015-05-13
N022580-003	9011906	2028-06-09	U-3398		2015-05-13
N022580-003	8580298	2029-05-15		Drug product
N022580-003	8580299	2029-06-14	U-3399
N022580-004	8895057	2028-06-09	U-3398		2014-12-18
N022580-004	8895058	2028-06-09		Drug product	2014-12-18
N022580-004	9011905	2028-06-09		Drug product	2015-05-13
N022580-004	9011906	2028-06-09	U-3398		2015-05-13
N022580-004	8580298	2029-05-15		Drug product
N022580-004	8580299	2029-06-14	U-3399

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022580-001	M-308	2027-09-13
N022580-002	M-308	2027-09-13
N022580-003	M-308	2027-09-13
N022580-004	M-308	2027-09-13

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.

Product history page 1 of 5 · 172 observed 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
2026-09-14 22:38:34	2026-08	N022580-001	QSYMIA	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-002	QSYMIA	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-003	QSYMIA	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-004	QSYMIA	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-07-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022580-001	QSYMIA	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-002	QSYMIA	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-003	QSYMIA	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-004	QSYMIA	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022580-001	QSYMIA	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022580-002	QSYMIA	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022580-003	QSYMIA	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022580-004	QSYMIA	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-001	QSYMIA	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-002	QSYMIA	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-003	QSYMIA	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-004	QSYMIA	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022580-001	QSYMIA	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022580-002	QSYMIA	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022580-003	QSYMIA	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022580-004	QSYMIA	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-001	QSYMIA	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-002	QSYMIA	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-003	QSYMIA	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-004	QSYMIA	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022580-001	QSYMIA	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022580-002	QSYMIA	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022580-003	QSYMIA	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022580-004	QSYMIA	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022580-001	QSYMIA	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022580-002	QSYMIA	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022580-003	QSYMIA	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022580-004	QSYMIA	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022580-001	QSYMIA	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022580-002	QSYMIA	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022580-003	QSYMIA	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022580-004	QSYMIA	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022580-001	QSYMIA	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022580-002	QSYMIA	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022580-003	QSYMIA	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2012-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022580-004	QSYMIA	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-07-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N022580-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022580-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022580-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022580-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022580-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022580-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022580-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022580-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022580-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022580-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022580-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022580-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022580-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022580-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022580-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022580-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022580-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022580-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022580-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022580-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022580-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022580-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022580-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022580-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022580-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022580-004	AB	1	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 29 · 1,128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022580-001	8895057	2028-06-09	U-3398		2014-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-001	8895058	2028-06-09		Drug product	2014-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-001	9011905	2028-06-09		Drug product	2015-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-001	9011906	2028-06-09	U-3398		2015-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-001	8580298	2029-05-15		Drug product	2013-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-001	8580299	2029-06-14	U-3399		2013-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-002	8895057	2028-06-09	U-3398		2014-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-002	8895058	2028-06-09		Drug product	2014-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-002	9011905	2028-06-09		Drug product	2015-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-002	9011906	2028-06-09	U-3398		2015-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-002	8580298	2029-05-15		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-002	8580299	2029-06-14	U-3399			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-003	8895057	2028-06-09	U-3398		2014-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-003	8895058	2028-06-09		Drug product	2014-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-003	9011905	2028-06-09		Drug product	2015-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-003	9011906	2028-06-09	U-3398		2015-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-003	8580298	2029-05-15		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-003	8580299	2029-06-14	U-3399			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-004	8895057	2028-06-09	U-3398		2014-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-004	8895058	2028-06-09		Drug product	2014-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-004	9011905	2028-06-09		Drug product	2015-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-004	9011906	2028-06-09	U-3398		2015-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-004	8580298	2029-05-15		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-004	8580299	2029-06-14	U-3399			`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022580-001	8895057	2028-06-09	U-3398		2014-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-001	8895058	2028-06-09		Drug product	2014-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-001	9011905	2028-06-09		Drug product	2015-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-001	9011906	2028-06-09	U-3398		2015-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-001	8580298	2029-05-15		Drug product	2013-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-001	8580299	2029-06-14	U-3399		2013-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-002	8895057	2028-06-09	U-3398		2014-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-002	8895058	2028-06-09		Drug product	2014-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-002	9011905	2028-06-09		Drug product	2015-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-002	9011906	2028-06-09	U-3398		2015-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-002	8580298	2029-05-15		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-002	8580299	2029-06-14	U-3399			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-003	8895057	2028-06-09	U-3398		2014-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-003	8895058	2028-06-09		Drug product	2014-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-003	9011905	2028-06-09		Drug product	2015-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-003	9011906	2028-06-09	U-3398		2015-05-13	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N022580-001	M-308	2027-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-002	M-308	2027-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-003	M-308	2027-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022580-004	M-308	2027-09-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022580-001	M-308	2027-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-002	M-308	2027-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-003	M-308	2027-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022580-004	M-308	2027-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022580-001	M-308	2027-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022580-002	M-308	2027-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022580-003	M-308	2027-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022580-004	M-308	2027-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-001	NPP	2025-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-001	M-308	2027-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-002	NPP	2025-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-002	M-308	2027-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-003	NPP	2025-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-003	M-308	2027-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-004	NPP	2025-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022580-004	M-308	2027-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022580-001	NPP	2025-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022580-001	M-308	2027-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022580-002	NPP	2025-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022580-002	M-308	2027-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022580-003	NPP	2025-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022580-003	M-308	2027-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022580-004	NPP	2025-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022580-004	M-308	2027-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-001	NPP	2025-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-001	M-308	2027-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-002	NPP	2025-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-002	M-308	2027-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-003	NPP	2025-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-003	M-308	2027-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-004	NPP	2025-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022580-004	M-308	2027-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022580-001	NPP	2025-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022580-001	M-308	2027-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022580-002	NPP	2025-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022580-002	M-308	2027-09-13	`b8a1b40f171c…`

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENTERMINE HYDROCHLORIDE	7.5 mg/1
TOPIRAMATE	46 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
876bd763-13fa-481e-b579-c2fc44dbf3c2	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
66993-781-30	phentermine and topiramate	30 in 1 BOTTLE, UNIT-DOSE	CAPSULE, EXTENDED RELEASE	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-781-30	EA - Each	66993-781	7d70416d-145b-4973-b5e8-caacd5be1e88	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
phentermine and topiramate	PHENTERMINE AND TOPIRAMATE	Prasco Laboratories	876bd763-13fa-481e-b579-c2fc44dbf3c2	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022580 application number: NDA022580 ndc (product): 66993-781
Qsymia	PHENTERMINE AND TOPIRAMATE	Vivus LLC	40dd5602-53da-45ac-bb4b-15789aba40f9	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022580 application number: NDA022580

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	876bd763-13fa-481e-b579-c2fc44dbf3c2	4
1302850	phentermine 15 MG / topiramate 92 MG 24HR Extended Release Oral Capsule	PSN	876bd763-13fa-481e-b579-c2fc44dbf3c2	4
1302839	phentermine 3.75 MG / topiramate 23 MG 24HR Extended Release Oral Capsule	PSN	876bd763-13fa-481e-b579-c2fc44dbf3c2	4
1302827	phentermine 7.5 MG / topiramate 46 MG 24HR Extended Release Oral Capsule	PSN	876bd763-13fa-481e-b579-c2fc44dbf3c2	4
1313059	24 HR phentermine 11.25 MG / topiramate 69 MG Extended Release Oral Capsule	SCD	876bd763-13fa-481e-b579-c2fc44dbf3c2	4
1302850	24 HR phentermine 15 MG / topiramate 92 MG Extended Release Oral Capsule	SCD	876bd763-13fa-481e-b579-c2fc44dbf3c2	4
1302839	24 HR phentermine 3.75 MG / topiramate 23 MG Extended Release Oral Capsule	SCD	876bd763-13fa-481e-b579-c2fc44dbf3c2	4
1302827	24 HR phentermine 7.5 MG / topiramate 46 MG Extended Release Oral Capsule	SCD	876bd763-13fa-481e-b579-c2fc44dbf3c2	4
1313059	phentermine 11.25 MG / topiramate 69 MG 24 HR Extended Release Oral Capsule	SY	876bd763-13fa-481e-b579-c2fc44dbf3c2	4
1302850	phentermine 15 MG / topiramate 92 MG 24 HR Extended Release Oral Capsule	SY	876bd763-13fa-481e-b579-c2fc44dbf3c2	4
1302839	phentermine 3.75 MG / topiramate 23 MG 24 HR Extended Release Oral Capsule	SY	876bd763-13fa-481e-b579-c2fc44dbf3c2	4
1302827	phentermine 7.5 MG / topiramate 46 MG 24 HR Extended Release Oral Capsule	SY	876bd763-13fa-481e-b579-c2fc44dbf3c2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
66993-781-30	66993078130	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (66993-781-30)	2025-06-01	No	No	Current