Phentermine Hydrochloride

Product NDC: 72789-433
Requested package NDC: 72789-433-14
11-digit product format: 727890433
Labeler code: 72789
Product ID: 72789-433_534a52dc-f6f2-cab4-e063-6294a90a8c5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA200272
Marketing category: ANDA
Marketing start: 2024-02-15
Marketing end: 2028-04-30
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
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
A200272-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		2011-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200272-001	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	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`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	A200272-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200272-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200272-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200272-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200272-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200272-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200272-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200272-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200272-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200272-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200272-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200272-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200272-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200272-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200272-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200272-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200272-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200272-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200272-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200272-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200272-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200272-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200272-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200272-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200272-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200272-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200272-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200272-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200272-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200272-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200272-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200272-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200272-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200272-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200272-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200272-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200272-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200272-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200272-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200272-001	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

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
19f1ce79-65f4-4bf4-a9ff-6ca0a131530f	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	SPL version
72789-433-07	Phentermine Hydrochloride	7 in 1 BOTTLE, PLASTIC	TABLET	7	13
72789-433-14	Phentermine Hydrochloride	14 in 1 BOTTLE, PLASTIC	TABLET	14	13
72789-433-15	Phentermine Hydrochloride	15 in 1 BOTTLE, PLASTIC	TABLET	15	13
72789-433-28	Phentermine Hydrochloride	28 in 1 BOTTLE, PLASTIC	TABLET	28	13
72789-433-30	Phentermine Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30	13
72789-433-45	Phentermine Hydrochloride	45 in 1 BOTTLE, PLASTIC	TABLET	45	13
72789-433-60	Phentermine Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET	60	13
72789-433-90	Phentermine Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET	90	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-433-07	EA - Each	72789-433	349ffa77-4c1b-429c-bf6b-be5ec179abd2	1	2024-12-10
72789-433-14	EA - Each	72789-433	1a8e7327-9ce4-4037-bddf-cca663b0c0ac	1	2025-09-12
72789-433-15	EA - Each	72789-433	ebd58352-fb37-4c47-ad0c-c4434af0845e	1	2024-11-05
72789-433-28	EA - Each	72789-433	b656b262-77f9-4e7c-9dc3-65cf229ff7bb	1	2024-12-10
72789-433-30	EA - Each	72789-433	40118594-acd9-417b-a14c-1f8be2219675	1	2024-12-10
72789-433-45	EA - Each	72789-433	c021b2e8-8c6a-4d41-8388-a73f825cdf7d	1	2024-12-10
72789-433-60	EA - Each	72789-433	8541ee62-3eb7-47ea-b56a-b28ab9b340ae	1	2024-11-05
72789-433-90	EA - Each	72789-433	0460063c-c5f0-453c-a76f-32d2471cebe8	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-433	PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	9	Current NDC, 8 package rows	20241109_19f1ce79-65f4-4bf4-a9ff-6ca0a131530f.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 · 10 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.	19f1ce79-65f4-4bf4-a9ff-6ca0a131530f	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272 ndc (package): 72789-433-14 ndc (product): 72789-433 ndc11 (package): 72789043314
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e6939fcf-3db2-492a-99ed-a384cdeea7a2	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	328d6a39-34f4-4b74-a1bf-6ec6005b1322	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	TAGI Pharma, Inc.	1993b181-f4f1-4451-92a0-7ed8f32598ba	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Precision Dose Inc.	8d5697b9-02e8-40c4-97c7-761d635243c8	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	f3b43443-dcf3-4a0d-a919-1be1bb9495ed	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	30b48126-45f3-21fa-e063-6294a90a968f	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine HCL	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	8fe6b65d-ca61-40f0-90fc-255dfd075611	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	bd7393cb-2b72-4ecd-ba03-801b635b7647	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	707af68e-1630-4f86-87ba-1a643d2b4ef9	2023-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-433-14	72789043314	14 TABLET in 1 BOTTLE, PLASTIC (72789-433-14)	14 tablet	2025-07-21	2028-04-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2026-06-02	HUMAN PRESCRIPTION DRUG LABEL	14