Phentermine Hydrochloride

Product NDC: 11534-157
11-digit product format: 115340157
Labeler code: 11534
Product ID: 11534-157_9d9ffca5-9d09-4d92-a8af-18f9f6b24989
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: phentermine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: SUNRISE PHARMACEUTICAL, INC.
Application: ANDA205019
Marketing category: ANDA
Marketing start: 2017-01-24
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 1.

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
A205019-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA		2014-12-05
A205019-002	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA		2014-12-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205019-001	AA
A205019-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205019-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2014-12-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205019-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2014-12-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205019-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205019-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205019-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205019-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205019-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205019-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205019-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205019-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205019-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205019-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205019-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205019-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205019-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205019-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205019-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205019-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205019-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205019-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205019-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205019-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205019-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205019-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205019-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205019-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205019-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205019-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205019-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205019-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205019-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205019-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205019-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205019-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205019-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205019-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205019-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205019-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205019-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205019-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205019-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205019-002	AA	1	`782e0a99824c…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
900038	Internal RxNorm lookup
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
a0439c85-5ede-4e02-aed2-47debd2c8eb2	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
32c2b0bd-1f13-4890-99e0-dcd2ea16e1ab	Product name	2	20230717
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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
11534-157-01	Phentermine Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		7
11534-157-03	Phentermine Hydrochloride	1000 in 1 BOTTLE	CAPSULE	1000		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11534-157-01	EA - Each	11534-157	ac441594-a5d5-426e-97a4-500032982a6f	1	2017-03-06
11534-157-03	EA - Each	11534-157	d7ccac07-9c21-4106-96fd-73322cb27858	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11534-157	PHENTERMINE HYDROCHLORIDE CAPSULE [SUNRISE PHARMACEUTICAL, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20220929_a0439c85-5ede-4e02-aed2-47debd2c8eb2.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 2 · 22 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.	130e6087-0ab6-4456-a781-d370f363dc38	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	d24aaa53-9c78-4c1b-9495-c785a9cf2b26	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	c53bd3c5-01f6-4a21-9e3c-aa4969a01b4b	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	fa5de92d-a5bf-4ae1-8e13-ad827aeebea3	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	a9270c14-499f-4c07-a1eb-c0aab5d8731f	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	d77f31b4-7e36-4a0a-a55b-78b4b6ab5cb7	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	70bc6f36-8087-4ccd-a396-a911c0ebae79	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	640d71d8-45c9-42fb-ad96-2f3ac60afc9c	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	fe78b5b4-47bf-484b-ab37-e0d7de6fad57	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e4508aa9-1e7a-4af7-829e-5fa353c92f5e	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	SUNRISE PHARMACEUTICAL, INC.	a0439c85-5ede-4e02-aed2-47debd2c8eb2	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019 ndc (product): 11534-157
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	a1bca4b5-df64-4bac-a3a2-67f5c1eddbce	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine HCL C-IV	PHENTERMINE HCL C-IV	Direct_Rx	e4a2996e-2bfa-376f-e053-2995a90a0ed1	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	DirectRx	ca683656-16a6-9602-e053-2a95a90aa895	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	c8516abe-5ad1-4b76-8e2c-96ee455979cf	2024-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	f427f067-f1a7-4d60-8ce0-90b20e2d4eb5	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	f50f5453-e06d-4e39-b868-9bdadf1d8baa	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	3c37d637-779d-4097-85ef-e4ce7d0fb86a	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	81751ece-8ccb-4aec-91ad-037c1d9fea53	2023-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Asclemed USA, Inc.	22683183-a828-47a4-9e52-38175d7c6f21	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205019 application number: ANDA205019

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	3c37d637-779d-4097-85ef-e4ce7d0fb86a	105
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	3c37d637-779d-4097-85ef-e4ce7d0fb86a	105
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	3c37d637-779d-4097-85ef-e4ce7d0fb86a	105
968766	phentermine HCl 15 MG Oral Capsule	PSN	f50f5453-e06d-4e39-b868-9bdadf1d8baa	104
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	f50f5453-e06d-4e39-b868-9bdadf1d8baa	104
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	f50f5453-e06d-4e39-b868-9bdadf1d8baa	104
968766	phentermine HCl 15 MG Oral Capsule	PSN	640d71d8-45c9-42fb-ad96-2f3ac60afc9c	103
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	640d71d8-45c9-42fb-ad96-2f3ac60afc9c	103
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	640d71d8-45c9-42fb-ad96-2f3ac60afc9c	103
968766	phentermine HCl 15 MG Oral Capsule	PSN	a1bca4b5-df64-4bac-a3a2-67f5c1eddbce	101
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	a1bca4b5-df64-4bac-a3a2-67f5c1eddbce	101
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	a1bca4b5-df64-4bac-a3a2-67f5c1eddbce	101
968766	phentermine HCl 15 MG Oral Capsule	PSN	c53bd3c5-01f6-4a21-9e3c-aa4969a01b4b	8
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	c53bd3c5-01f6-4a21-9e3c-aa4969a01b4b	8
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	c53bd3c5-01f6-4a21-9e3c-aa4969a01b4b	8
968766	phentermine HCl 15 MG Oral Capsule	PSN	70bc6f36-8087-4ccd-a396-a911c0ebae79	7
968766	phentermine HCl 15 MG Oral Capsule	PSN	a0439c85-5ede-4e02-aed2-47debd2c8eb2	7
900038	phentermine HCl 30 MG Oral Capsule	PSN	a0439c85-5ede-4e02-aed2-47debd2c8eb2	7
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	a0439c85-5ede-4e02-aed2-47debd2c8eb2	7
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	70bc6f36-8087-4ccd-a396-a911c0ebae79	7
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	a0439c85-5ede-4e02-aed2-47debd2c8eb2	7
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	70bc6f36-8087-4ccd-a396-a911c0ebae79	7
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	a0439c85-5ede-4e02-aed2-47debd2c8eb2	7
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	a0439c85-5ede-4e02-aed2-47debd2c8eb2	7
968766	phentermine HCl 15 MG Oral Capsule	PSN	d7984a71-d70a-3e88-e053-2a95a90a97a2	4
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	d7984a71-d70a-3e88-e053-2a95a90a97a2	4
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	d7984a71-d70a-3e88-e053-2a95a90a97a2	4
968766	phentermine HCl 15 MG Oral Capsule	PSN	d24aaa53-9c78-4c1b-9495-c785a9cf2b26	3
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	d24aaa53-9c78-4c1b-9495-c785a9cf2b26	3
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	d24aaa53-9c78-4c1b-9495-c785a9cf2b26	3
968766	phentermine HCl 15 MG Oral Capsule	PSN	5c1f88ba-d7d6-4b48-b951-c5e65d87e874	2
968766	phentermine HCl 15 MG Oral Capsule	PSN	e4a2996e-2bfa-376f-e053-2995a90a0ed1	2
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	5c1f88ba-d7d6-4b48-b951-c5e65d87e874	2
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	e4a2996e-2bfa-376f-e053-2995a90a0ed1	2
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	5c1f88ba-d7d6-4b48-b951-c5e65d87e874	2
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	e4a2996e-2bfa-376f-e053-2995a90a0ed1	2
968766	phentermine HCl 15 MG Oral Capsule	PSN	22683183-a828-47a4-9e52-38175d7c6f21	1
900038	phentermine HCl 30 MG Oral Capsule	PSN	22683183-a828-47a4-9e52-38175d7c6f21	1
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	22683183-a828-47a4-9e52-38175d7c6f21	1
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	22683183-a828-47a4-9e52-38175d7c6f21	1
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	22683183-a828-47a4-9e52-38175d7c6f21	1
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	22683183-a828-47a4-9e52-38175d7c6f21	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11534-157-01	11534015701	100 CAPSULE in 1 BOTTLE (11534-157-01)	100 capsule	2017-01-24	0000-00-00	No	No	Current
11534-157-03	11534015703	1000 CAPSULE in 1 BOTTLE (11534-157-03)	1000 capsule	2017-01-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	2
Phentermine Hydrochloride	Calvin Scott & Co., Inc. \| Sunrise Pharmaceutical Inc	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	3
Phentermine Hydrochloride	A-S Medication Solutions	2026-03-04	HUMAN PRESCRIPTION DRUG LABEL	8
Phentermine Hydrochloride	Preferred Pharmaceuticals, Inc.	2025-09-08	HUMAN PRESCRIPTION DRUG LABEL	7
Phentermine Hydrochloride	Bryant Ranch Prepack	2025-09-05	HUMAN PRESCRIPTION DRUG LABEL	103
Phentermine Hydrochloride	SUNRISE PHARMACEUTICAL, INC.	2025-07-08	HUMAN PRESCRIPTION DRUG LABEL	7
Phentermine Hydrochloride	Bryant Ranch Prepack	2025-05-12	HUMAN PRESCRIPTION DRUG LABEL	101
Phentermine HCL C-IV	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Phentermine Hydrochloride	Bryant Ranch Prepack	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	104
Phentermine Hydrochloride	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	105
Phentermine Hydrochloride	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-09-01	HUMAN PRESCRIPTION DRUG LABEL	1
Phentermine Hydrochloride	NuCare Pharmaceuticals,Inc.	2023-04-11	HUMAN PRESCRIPTION DRUG LABEL	4
Phentermine Hydrochloride	Proficient Rx LP	2022-03-01	HUMAN PRESCRIPTION DRUG LABEL	2