Phentermine Hydrochloride

Product NDC: 72789-560
11-digit product format: 727890560
Labeler code: 72789
Product ID: 72789-560_4f6c3636-135a-5b39-e063-6294a90a9310
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA040190
Marketing category: ANDA
Marketing start: 2014-05-01
Substance: PHENTERMINE HYDROCHLORIDE
Active strength: 37.5 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: 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040190-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		1997-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040190-001	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	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`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	A040190-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040190-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040190-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040190-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040190-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040190-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040190-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040190-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040190-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040190-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040190-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040190-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040190-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040190-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040190-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040190-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040190-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040190-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040190-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040190-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040190-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040190-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040190-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040190-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040190-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040190-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040190-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040190-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040190-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040190-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040190-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040190-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040190-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040190-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040190-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040190-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040190-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040190-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040190-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040190-001	AA	1	`f41ea6bd6efb…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENTERMINE HYDROCHLORIDE	37.5 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
803353	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
eae1d7f9-733c-434b-9199-5f7052e541da	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
72789-560-28	Phentermine Hydrochloride	28 in 1 BOTTLE, PLASTIC	TABLET	28		2
72789-560-30	Phentermine Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-560-28	EA - Each	72789-560	9a59944a-ae8d-4bf2-b0ec-d93749ed2727	1	2026-05-22
72789-560-30	EA - Each	72789-560	4ffe7833-6b94-436e-8216-b81b6375c0af	1	2026-05-22

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 Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	eae1d7f9-733c-434b-9199-5f7052e541da	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040190 application number: ANDA040190 ndc (product): 72789-560
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Elite Laboratories, Inc.	0b7ad9c0-9e1e-4a69-802b-28f44267e34d	2017-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040190 application number: ANDA040190

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
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	eae1d7f9-733c-434b-9199-5f7052e541da	2
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	eae1d7f9-733c-434b-9199-5f7052e541da	2
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	eae1d7f9-733c-434b-9199-5f7052e541da	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72789-560-28	72789056028	28 TABLET in 1 BOTTLE, PLASTIC (72789-560-28)	28 tablet	2026-04-14	No	No	Current
72789-560-30	72789056030	30 TABLET in 1 BOTTLE, PLASTIC (72789-560-30)	30 tablet	2026-04-14	No	No	Current