Phentermine Hydrochloride

Product NDC: 0527-1310
11-digit product format: 005271310
Labeler code: 0527
Product ID: 0527-1310_13517af4-9eee-422d-ae02-2a0f09101d74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA087022
Marketing category: ANDA
Marketing start: 2007-12-01
Marketing end: 0000-00-00
Substance: PHENTERMINE HYDROCHLORIDE
Active strength: 30 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0527-1310		D	Discontinued by firm	2026-08-07
excluded package	package	0527-1310	0527-1310-01	D	Discontinued by firm	2026-08-07
excluded package	package	0527-1310	0527-1310-10	D	Discontinued by firm	2026-08-07

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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0527-1310-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0527-1310-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0527-1310-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0527-1310-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-1310-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-1310-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-1310-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-1310-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-1310-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-1310-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-1310-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-1310-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-1310-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-1310-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-1310-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-1310-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-1310-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-1310-01	`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
A087022-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1983-02-03
A087022-002	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL			2012-01-20

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	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087022-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087022-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087022-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A087022-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087022-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A087022-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087022-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A087022-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087022-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A087022-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087022-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A087022-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087022-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087022-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087022-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A087022-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087022-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A087022-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087022-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A087022-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087022-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A087022-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087022-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A087022-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087022-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A087022-002	AA	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A087022-001	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A087022-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087022-001	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087022-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087022-001	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A087022-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087022-001	AA	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A087022-002	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087022-001	AA	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087022-002	AA	1	`cb3db0bc1861…`

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
0527-1310-01	2024-01-30	C162847	48780-1	1030e364-fd13-111a-e063-dadaa90a10e2	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
0527-1310-10	2024-01-30	C162847	48780-1	1030e364-fd13-111a-e063-dadaa90a10e2	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1310-01	EA - Each	0527-1310	b96c06ba-d9e6-4224-a81c-102a0ed2e7cf	1	2012-07-24
0527-1310-10	EA - Each	0527-1310	f23963ee-99de-41f0-9ded-48b543f57cef	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENTERMINE HYDROCHLORIDE	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
PHENTERMINE	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENTERMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	16
PHENTERMINE HYDROCHLORIDE	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
PHENTERMINE	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	2
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
Anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
D&C Yellow NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C Blue NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C Blue NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C Red NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C Red NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
Methyl Alcohol	INACTIVE INGREDIENT	Y4S76JWI15	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
Propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
shellac	INACTIVE INGREDIENT	46N107B71O	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	1
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]	1

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
900038	phentermine HCl 30 MG Oral Capsule	PSN	8a947cf6-c578-0405-e053-2995a90a3e0e	6
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	8a947cf6-c578-0405-e053-2995a90a3e0e	6
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	8a947cf6-c578-0405-e053-2995a90a3e0e	6
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	8a947cf6-c578-0405-e053-2995a90a3e0e	6
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	8a947cf6-c578-0405-e053-2995a90a3e0e	6
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	8a947cf6-c578-0405-e053-2995a90a3e0e	6
900038	phentermine HCl 30 MG Oral Capsule	PSN	a56c3aa5-ca6f-4c14-ab07-fbb3f8be060c	4
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	a56c3aa5-ca6f-4c14-ab07-fbb3f8be060c	4
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	a56c3aa5-ca6f-4c14-ab07-fbb3f8be060c	4
900038	phentermine HCl 30 MG Oral Capsule	PSN	9128e039-24e8-45a7-bf22-0309419f86ec	2
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	9128e039-24e8-45a7-bf22-0309419f86ec	2
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	9128e039-24e8-45a7-bf22-0309419f86ec	2
900038	phentermine HCl 30 MG Oral Capsule	PSN	7f871c5e-02e5-40f3-a60d-c9d2e9f5ce66	1
900038	phentermine HCl 30 MG Oral Capsule	PSN	29bd88e3-215d-4c34-b22a-df159a2dd98d	1
900038	phentermine HCl 30 MG Oral Capsule	PSN	c8b12e5c-00c9-46e9-943b-c2908113f5bd	1
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	c8b12e5c-00c9-46e9-943b-c2908113f5bd	1
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	29bd88e3-215d-4c34-b22a-df159a2dd98d	1
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	7f871c5e-02e5-40f3-a60d-c9d2e9f5ce66	1
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	7f871c5e-02e5-40f3-a60d-c9d2e9f5ce66	1
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	29bd88e3-215d-4c34-b22a-df159a2dd98d	1
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	c8b12e5c-00c9-46e9-943b-c2908113f5bd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-1310-01	00527131001	100 CAPSULE in 1 BOTTLE (0527-1310-01)	100 capsule	2007-12-01	0000-00-00	No	No	Current
0527-1310-10	00527131010	1000 CAPSULE in 1 BOTTLE (0527-1310-10)	1000 capsule	2007-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENTERMINE HCL C-IV	Direct_Rx	2023-04-12	HUMAN PRESCRIPTION DRUG LABEL	6
Phentermine Hydrochloride	NuCare Pharmaceuticals, Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	4
Phentermine Hydrochloride	Preferred Pharmaceuticals Inc.	2021-01-21	HUMAN PRESCRIPTION DRUG LABEL	1
Phentermine Hydrochloride	Proficient Rx LP	2020-03-01	HUMAN PRESCRIPTION DRUG LABEL	2
Phentermine Hydrochloride	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-05-29	HUMAN PRESCRIPTION DRUG LABEL	1
Phentermine Hydrochloride	Unit Dose Services	2017-09-25	HUMAN PRESCRIPTION DRUG LABEL	4
Phentermine Hydrochloride	Lannett Company, Inc.	2017-04-03	HUMAN PRESCRIPTION DRUG LABEL	27
Phentermine Hydrochloride	Blenheim Pharmacal, Inc.	2015-04-09	HUMAN PRESCRIPTION DRUG LABEL	2
PHENTERMINE HYDROCHLORIDE CAPSULES, USP CIV	H.J. Harkins Company, Inc. \| Lannett Company, Inc.	2011-10-28	HUMAN PRESCRIPTION DRUG LABEL	1
PHENTERMINE HYDROCHLORIDE CAPSULES, USP CIV	Rebel Distributors Corp	2010-11-10	HUMAN PRESCRIPTION DRUG LABEL	1