Phentermine Hydrochloride

Product NDC: 0527-1308
11-digit product format: 005271308
Labeler code: 0527
Product ID: 0527-1308_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

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
0527-1308-01	2024-01-30	C162847	48780-1	1030e364-fd13-111a-e063-dadaa90a10e2	4af88a94-22c3-4da1-b8d9-a73ef68a51b6
0527-1308-10	2024-01-30	C162847	48780-1	1030e364-fd13-111a-e063-dadaa90a10e2	4af88a94-22c3-4da1-b8d9-a73ef68a51b6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1308-01	EA - Each	0527-1308	d5fc7727-d2db-4330-878b-a6ae54ff5780	1	2012-07-24
0527-1308-10	EA - Each	0527-1308	7805f4bc-13fd-44f1-a5da-1450d39a5d4a	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 [BLENHEIM PHARMACAL, INC.]	1
PHENTERMINE HYDROCHLORIDE	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
PHENTERMINE HYDROCHLORIDE	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
PHENTERMINE HYDROCHLORIDE	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
PHENTERMINE	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
PHENTERMINE	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
PHENTERMINE	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
Anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
D&C Red NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
D&C Yellow NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C Blue NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
FD&C Blue NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
FD&C Red NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
Methyl Alcohol	INACTIVE INGREDIENT	Y4S76JWI15	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
Propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
shellac	INACTIVE INGREDIENT	46N107B71O	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENTERMINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENTERMINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, 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	1c0195e8-902e-4c73-86e5-0197122154ed	16
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	1c0195e8-902e-4c73-86e5-0197122154ed	16
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	1c0195e8-902e-4c73-86e5-0197122154ed	16
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	3e5b49f1-314d-4d3c-9278-1c6880789bf6	3
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	3e5b49f1-314d-4d3c-9278-1c6880789bf6	3
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	3e5b49f1-314d-4d3c-9278-1c6880789bf6	3
900038	phentermine HCl 30 MG Oral Capsule	PSN	c5b66bc3-13d9-4902-9719-a2d41b743c9f	1
900038	phentermine HCl 30 MG Oral Capsule	PSN	56f0bb46-57d5-4556-a00c-4f6820e4e6ce	1
900038	phentermine HCl 30 MG Oral Capsule	PSN	3c8f78be-1852-4db9-bfb0-78dee816cbe8	1
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	56f0bb46-57d5-4556-a00c-4f6820e4e6ce	1
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	3c8f78be-1852-4db9-bfb0-78dee816cbe8	1
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	c5b66bc3-13d9-4902-9719-a2d41b743c9f	1
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	56f0bb46-57d5-4556-a00c-4f6820e4e6ce	1
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	3c8f78be-1852-4db9-bfb0-78dee816cbe8	1
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	c5b66bc3-13d9-4902-9719-a2d41b743c9f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-1308-01	00527130801	100 CAPSULE in 1 BOTTLE (0527-1308-01)	100 capsule	2007-12-01	0000-00-00	No	No	Current
0527-1308-10	00527130810	1000 CAPSULE in 1 BOTTLE (0527-1308-10)	1000 capsule	2007-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phentermine Hydrochloride	A-S Medication Solutions	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	3
Phentermine Hydrochloride	A-S Medication Solutions	2020-07-13	HUMAN PRESCRIPTION DRUG LABEL	16
Phentermine Hydrochloride	Unit Dose Services	2017-09-25	HUMAN PRESCRIPTION DRUG LABEL	4
PHENTERMINE HYDROCHLORIDE CAPSULES, USP CIV	Blenheim Pharmacal, Inc.	2010-08-24	HUMAN PRESCRIPTION DRUG LABEL	1
PHENTERMINE HYDROCHLORIDE CAPSULES, USP CIV	Physicians Total Care, Inc.	2010-07-19	HUMAN PRESCRIPTION DRUG LABEL	1
PHENTERMINE HYDROCHLORIDE CAPSULES, USP CIV	STAT RX USA LLC	2010-06-09	HUMAN PRESCRIPTION DRUG LABEL	1

Phentermine Hydrochloride

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#