Phentermine Hydrochloride

Product NDC: 68071-2640
11-digit product format: 680712640
Labeler code: 68071
Product ID: 68071-2640_ea3be7c7-2d90-0ace-e053-2a95a90a47df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: phentermine hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA205019
Marketing category: ANDA
Marketing start: 2017-01-24
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68071-2640		I	Inactivated by FDA	2026-08-03
excluded package	package	68071-2640	68071-2640-3	I	Inactivated by FDA	2026-08-03
excluded package	package	68071-2640	68071-2640-6	I	Inactivated by FDA	2026-08-03
excluded package	package	68071-2640	68071-2640-8	I	Inactivated by FDA	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2640-8	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2640-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2640-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2640-8	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2640-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2640-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2640-8	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2640-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2640-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2640-8	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2640-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2640-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2640-8	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2640-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2640-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2640-8	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2640-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2640-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2640-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2640-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2640-8	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2640-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2640-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2640-8	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2640-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2640-6	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2640-8	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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
68071-2640-3	2025-01-30	C162847	48780-1	2cef2736-663e-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE hydrochloride capsules USP, for oral use CIV Initial U.S. Approval: 1959
68071-2640-6	2025-01-30	C162847	48780-1	2cef2736-663e-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE hydrochloride capsules USP, for oral use CIV Initial U.S. Approval: 1959
68071-2640-8	2025-01-30	C162847	48780-1	2cef2736-663e-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE hydrochloride capsules USP, for oral use CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-2640-3	Phentermine Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	4
68071-2640-6	Phentermine Hydrochloride	60 in 1 BOTTLE	CAPSULE	60	4
68071-2640-8	Phentermine Hydrochloride	28 in 1 BOTTLE	CAPSULE	28	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2640	PHENTERMINE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]	4	Legacy NDC, 3 package rows	20230412_d7984a71-d70a-3e88-e053-2a95a90a97a2.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
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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2640-3	68071264003	30 CAPSULE in 1 BOTTLE (68071-2640-3)	30 capsule	2022-02-09	0000-00-00	No	No	Current
68071-2640-6	68071264006	60 CAPSULE in 1 BOTTLE (68071-2640-6)	60 capsule	2022-02-09	0000-00-00	No	No	Current
68071-2640-8	68071264008	28 in 1 BOTTLE						Historical