Phentermine Hydrochloride

Manufacturer: H.J. Harkins Company, Inc. | H.J. Harkins Comapny., Inc.
Effective date: 2018-01-03
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 20:25:16

Label at a glance#

ProductPhentermine Hydrochloride

Active ingredientPHENTERMINE HYDROCHLORIDE

Label structure3 sections

Label contents#

Full prescribing information#

Indications & Usage

INDICATIONS & USAGE SECTION

Phentermine hydrochloride tablets USP are indicated as a short-term (a few weeks) adjunct in a regimen

of weight reduction based on exercise, behavioral modification and caloric restriction in the

management of exogenous obesity for patients with an initial body mass index greater than or equal to

30 kg/m , or greater than or equal to 27 kg/m in the presence of other risk factors (e.g., controlled

hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (BMI) based on various heights and weights.

BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

Phentermine Indications and usage

Description

DESCRIPTION SECTION

Phentermine hydrochloride USP is a sympathomimetic amine anorectic. Its chemical name is a,a- dimethylphenethylamine hydrochloride. The structural formula is as follows:

Phentermine hydrochloride USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.

Phentermine hydrochloride tablets USP are available as an oral tablet containing 37.5 mg of phentermine hydrochloride USP (equivalent to 30 mg of phentermine base). Each phentermine hydrochloride tablet USP also contains the inactive ingredients microcrystalline cellulose, pregelatinized starch, anhydrous lactose, crospovidone, colloidal silicon dioxide, magnesium stearate, sucrose, corn starch and FD&C Blue #1. Phentermine

Package and Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

52959-0812-21

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	2
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	2
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PHENTERMINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Source image
Data code	Code 39	13107006199	52959081221.jpg
Data code	Code 39	PHE06QV59G	52959081221.jpg
Data code	Data Matrix	000A9EB60000517233PHE06QV59G	52959081221.jpg

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-812-21	2020-01-31	C162847	48780-1	9d75b9d0-4312-f424-e053-dadaa90a57ce	5486d426-4704-0bed-e054-00144ff8d46c
52959-812-45	2020-01-31	C162847	48780-1	9d75b9d0-4312-f424-e053-dadaa90a57ce	5486d426-4704-0bed-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-812-21	Phentermine Hydrochloride	21 in 1 BOTTLE	TABLET	21		2
52959-812-45	Phentermine Hydrochloride	45 in 1 CONTAINER	TABLET	45		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-812	PHENTERMINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 2 package rows	20180103_5486d426-4704-0bed-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-812-07	EA - Each	52959-812	100113a3-fcfb-4f27-b704-5d15323757e7	1	2012-07-24
52959-812-10	EA - Each	52959-812	f8d66d7e-77a1-4806-bc7f-5c4cd1bb161b	1	2012-07-24
52959-812-11	EA - Each	52959-812	adde597c-c9a7-4739-b969-36e2862cc694	1	2012-07-24
52959-812-14	EA - Each	52959-812	ec7e123b-e78b-4269-8f7d-203520f34838	1	2012-07-24
52959-812-20	EA - Each	52959-812	f0cbdd02-2245-4c74-a59e-221158df5355	1	2012-07-24
52959-812-22	EA - Each	52959-812	65eb80fa-60e5-428f-806a-1632223654eb	1	2012-07-24
52959-812-30	EA - Each	52959-812	b76a984e-d02a-4c5c-97d1-fda566361cfe	1	2012-07-24
52959-812-60	EA - Each	52959-812	98fbdcb9-6fa9-432b-ba11-add088b14b60	1	2012-07-24
52959-812-90	EA - Each	52959-812	82da4eb5-04d2-4b06-81f7-db0f64751391	1	2012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Phentermine Hydrochloride
PHENTERMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52959-812	52959-812-21, 52959-812-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PHENTERMINE HYDROCHLORIDE	0K2I505OTV	ACTIB

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203068-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		2014-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203068-001	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 2 · 43 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	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A203068-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203068-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203068-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203068-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203068-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203068-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203068-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203068-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203068-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203068-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203068-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203068-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203068-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203068-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203068-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203068-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203068-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203068-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203068-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203068-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203068-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203068-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203068-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203068-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203068-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203068-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203068-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203068-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203068-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203068-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203068-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203068-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203068-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203068-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203068-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203068-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203068-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203068-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203068-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203068-001	AA	1	`f41ea6bd6efb…`

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
61e4300d-6f7e-6951-e053-2a91aa0a974a			5486d426-4704-0bed-e054-00144ff8d46c	2018-01-03		Exact identifier spl id: 61e4300d-6f7e-6951-e053-2a91aa0a974a spl set id: 5486d426-4704-0bed-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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