Phentermine Hydrochloride

Product NDC: 84053-026
11-digit product format: 840530026
Labeler code: 84053
Product ID: 84053-026_3a9e49c7-cd54-cb92-e063-6394a90a1978
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Martek Pharmacal Co.
Application: ANDA040886
Marketing category: ANDA
Marketing start: 2024-05-31
Substance: PHENTERMINE HYDROCHLORIDE
Active strength: 15 mg/1
Pharmacologic classes: Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040886-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA		2008-03-31
A040886-002	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA		2008-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040886-001	AA
A040886-002	AA

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 3 · 86 observed 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	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040886-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2008-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040886-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2008-03-31	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A040886-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040886-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040886-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040886-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040886-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040886-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040886-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040886-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040886-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040886-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040886-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040886-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040886-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040886-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040886-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040886-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040886-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040886-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040886-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040886-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040886-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040886-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040886-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040886-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040886-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040886-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040886-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040886-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040886-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040886-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040886-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040886-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040886-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040886-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040886-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040886-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040886-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040886-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040886-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040886-002	AA	1	`74a2ff9319b5…`

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 Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENTERMINE HYDROCHLORIDE	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
968766	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
1fe86035-19ef-4944-ad81-c0167a8e7fec	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
84053-026-21	Phentermine Hydrochloride	21 in 1 BOTTLE	CAPSULE	21		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84053-026	PHENTERMINE HYDROCHLORIDE CAPSULE [MARTEK PHARMACAL CO.]	1	Current NDC, 1 package rows	20240531_1fe86035-19ef-4944-ad81-c0167a8e7fec.zip

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	2f3b738f-d66b-40c1-8e69-bcd50bce3e47	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4000c00f-aa6c-4ea5-af0e-149dde3c74db	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f115ad6d-cf62-40e7-89d1-6183a9b5071f	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2abc445c-daa8-7326-e054-00144ff88e88	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	5234cabd-6b3e-404d-a0cd-256ee5fcc8f1	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	1fe86035-19ef-4944-ad81-c0167a8e7fec	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886 ndc (product): 84053-026
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0b4d847a-fcda-df31-e063-6294a90a0c5e	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	7f1c3a5d-dd9b-4441-a483-aa5777f8e40c	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	KVK-Tech, Inc.	b963f7bb-fa65-4e28-81c9-282fbe70a6a6	2024-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Proficient Rx LP	3a3259ec-ded3-427f-843d-928d130de3da	2020-03-01	Adverse reactions	Exact identifier application applno (ANDA): 040886 application number: ANDA040886

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0K2I505OTV	PHENTERMINE HYDROCHLORIDE	1197-21-3	PHENTERMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
968766	phentermine HCl 15 MG Oral Capsule	PSN	1fe86035-19ef-4944-ad81-c0167a8e7fec	2
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	1fe86035-19ef-4944-ad81-c0167a8e7fec	2
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	1fe86035-19ef-4944-ad81-c0167a8e7fec	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84053-026-21	84053002621	21 CAPSULE in 1 BOTTLE (84053-026-21)	21 capsule	2024-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phentermine Hydrochloride	Martek Pharmacal Co. \| Unit Dose Solutions	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	2