NDC 11534-160

Phentermine hydrochloride

Phentermine Hydrochloride

Phentermine hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sunrise Pharmaceutical, Inc.. The primary component is Phentermine Hydrochloride.

Product ID11534-160_59600473-2368-424d-9c89-4661a987b105
NDC11534-160
Product TypeHuman Prescription Drug
Proprietary NamePhentermine hydrochloride
Generic NamePhentermine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-01-24
Marketing CategoryANDA / ANDA
Application NumberANDA205008
Labeler NameSUNRISE PHARMACEUTICAL, INC.
Substance NamePHENTERMINE HYDROCHLORIDE
Active Ingredient Strength38 mg/1
Pharm ClassesAppetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 11534-160-01

100 TABLET in 1 BOTTLE (11534-160-01)
Marketing Start Date2017-01-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11534-160-01 [11534016001]

Phentermine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA205008
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-24

NDC 11534-160-03 [11534016003]

Phentermine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA205008
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-24

NDC 11534-160-30 [11534016030]

Phentermine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA205008
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-24

Drug Details

Active Ingredients

IngredientStrength
PHENTERMINE HYDROCHLORIDE37.5 mg/1

OpenFDA Data

SPL SET ID:43024f64-2d77-49a9-80fd-ad07a86c69a3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 803348
  • 803353

    • Pharmacological Class

    • Appetite Suppression [PE]
    • Increased Sympathetic Activity [PE]
    • Sympathomimetic Amine Anorectic [EPC]

    NDC Crossover Matching brand name "Phentermine hydrochloride" or generic name "Phentermine Hydrochloride"

    NDCBrand NameGeneric Name
    0185-0644phentermine hydrochloridephentermine hydrochloride
    0185-0647phentermine hydrochloridephentermine hydrochloride
    0185-5000phentermine hydrochloridephentermine hydrochloride
    0527-0597Phentermine HydrochloridePhentermine Hydrochloride
    0527-1308Phentermine HydrochloridePhentermine Hydrochloride
    0527-1310Phentermine HydrochloridePhentermine Hydrochloride
    0527-1438Phentermine HydrochloridePhentermine Hydrochloride
    0527-1445Phentermine HydrochloridePhentermine Hydrochloride
    0527-1742Phentermine HydrochloridePhentermine Hydrochloride
    0527-1743Phentermine HydrochloridePhentermine Hydrochloride
    10544-098Phentermine HydrochloridePhentermine Hydrochloride
    10544-099Phentermine HydrochloridePhentermine Hydrochloride
    10544-116Phentermine HydrochloridePhentermine Hydrochloride
    10544-552Phentermine HydrochloridePhentermine Hydrochloride
    10544-592Phentermine HydrochloridePhentermine Hydrochloride
    10544-593Phentermine HydrochloridePhentermine Hydrochloride
    10544-602Phentermine HydrochloridePhentermine Hydrochloride
    10544-620Phentermine HydrochloridePhentermine Hydrochloride
    10702-025Phentermine HydrochloridePhentermine Hydrochloride
    10702-026Phentermine HydrochloridePhentermine Hydrochloride
    10702-027Phentermine HydrochloridePhentermine Hydrochloride
    10702-028Phentermine HydrochloridePhentermine Hydrochloride
    10702-029Phentermine HydrochloridePhentermine Hydrochloride
    10702-067Phentermine HydrochloridePhentermine Hydrochloride
    11534-157Phentermine Hydrochloridephentermine hydrochloride
    11534-159Phentermine hydrochloridephentermine hydrochloride
    68071-3241Phentermine HydrochloridePhentermine Hydrochloride
    68382-670Phentermine HydrochloridePhentermine Hydrochloride
    68382-703Phentermine HydrochloridePhentermine Hydrochloride
    68382-704Phentermine HydrochloridePhentermine Hydrochloride
    68387-690Phentermine HydrochloridePhentermine Hydrochloride
    68788-8950Phentermine HydrochloridePhentermine Hydrochloride
    68788-8942Phentermine HydrochloridePhentermine Hydrochloride
    68788-9271Phentermine HydrochloridePhentermine Hydrochloride
    69677-293Phentermine HydrochloridePhentermine Hydrochloride
    70771-1201Phentermine HydrochloridePhentermine Hydrochloride
    70771-1202Phentermine HydrochloridePhentermine Hydrochloride
    70771-1200Phentermine HydrochloridePhentermine Hydrochloride
    71335-0350Phentermine HydrochloridePhentermine Hydrochloride
    71335-0646Phentermine hydrochloridePhentermine hydrochloride
    71335-0419Phentermine HydrochloridePhentermine Hydrochloride
    71335-0564Phentermine HydrochloridePhentermine Hydrochloride
    71335-0678Phentermine HydrochloridePhentermine Hydrochloride
    71335-0474Phentermine HydrochloridePhentermine Hydrochloride
    71335-0030Phentermine HydrochloridePhentermine Hydrochloride
    71335-0161Phentermine HydrochloridePhentermine Hydrochloride
    75921-025Phentermine HydrochloridePhentermine Hydrochloride
    11534-176Phentermine HydrochloridePhentermine Hydrochloride
    11534-160Phentermine hydrochloridePhentermine hydrochloride
    12634-516Phentermine HydrochloridePhentermine Hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.