This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

Phentermine Hydrochloride

Read time: 1 mins
Marketing start date: 14 Nov 2024
...
 

Summary of product characteristics


Effective Time

20221013

Version

4

Spl Product Data Elements

Phentermine Hydrochloride Phentermine Hydrochloride PHENTERMINE HYDROCHLORIDE PHENTERMINE SILICON DIOXIDE CROSPOVIDONE (15 MPA.S AT 5%) MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE PEPPERMINT POVIDONE K30 SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE SUCRALOSE TALC white to off-white peppermint flavour round 703 Phentermine Hydrochloride Phentermine Hydrochloride PHENTERMINE HYDROCHLORIDE PHENTERMINE SILICON DIOXIDE CROSPOVIDONE (15 MPA.S AT 5%) MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE PEPPERMINT POVIDONE K30 SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE SUCRALOSE TALC white to off-white peppermint flavour oval 704 Phentermine Hydrochloride Phentermine Hydrochloride PHENTERMINE HYDROCHLORIDE PHENTERMINE SILICON DIOXIDE CROSPOVIDONE (15 MPA.S AT 5%) MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE PEPPERMINT POVIDONE K30 SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE SUCRALOSE TALC WHITE TO OFF-WHITE PEPPERMINT ROUND 670

Application Number

ANDA204663

Brand Name

Phentermine Hydrochloride

Generic Name

Phentermine Hydrochloride

Product Ndc

70771-1200

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1200-1 in bottle of 100 Tablets Phentermine Hydrochloride Orally Disintegrating Tablets, 15 mg Rx only 100 Tablets NDC 70771-1201-1 in bottle of 100 Tablets Phentermine Hydrochloride Orally Disintegrating Tablets, 30 mg Rx only 100 Tablets NDC 70771-1202-1 in bottle of 100 Tablets Phentermine Hydrochloride Orally Disintegrating Tablets, 37.5 mg Rx only 100 Tablets Phentermine hcl odtab 15mg-image 02 phentermine hcl odtab 30mg-image 03 phentermine hcl odtab 37.5 mg

Drug section

CME banner

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.