FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
43547-404
11-digit product format
435470404
Labeler code
43547
Product ID
43547-404_e7560e52-6bb6-4f57-be5b-5132bb9f5471
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare U.S., LLC
Application
ANDA040377
Marketing category
ANDA
Marketing start
2002-01-04
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
37.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui803353

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
32c2b0bd-1f13-4890-99e0-dcd2ea16e1abProduct name220230717
ebeae3eb-385d-62da-8827-5ffa80b14e90Product name220170810
1d682039-1122-1cb7-f3f4-c0a028b98748Product name420170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56Product name320161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43547-404-032020-03-09C16284748780-19d75b9d0-8c0b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS, USP safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS, USP. PHENTERMINE HYDROCHLORIDE tablets, USP CIV for oral use Initial U.S. Approval: 1959
43547-404-102020-03-09C16284748780-19d75b9d0-8c0b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS, USP safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS, USP. PHENTERMINE HYDROCHLORIDE tablets, USP CIV for oral use Initial U.S. Approval: 1959
43547-404-112020-03-09C16284748780-19d75b9d0-8c0b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS, USP safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS, USP. PHENTERMINE HYDROCHLORIDE tablets, USP CIV for oral use Initial U.S. Approval: 1959
43547-404-032020-01-31C16284748780-19d75b9d0-8c0b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS, USP safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS, USP. PHENTERMINE HYDROCHLORIDE tablets, USP CIV for oral use Initial U.S. Approval: 1959
43547-404-102020-01-31C16284748780-19d75b9d0-8c0b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS, USP safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS, USP. PHENTERMINE HYDROCHLORIDE tablets, USP CIV for oral use Initial U.S. Approval: 1959
43547-404-112020-01-31C16284748780-19d75b9d0-8c0b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS, USP safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS, USP. PHENTERMINE HYDROCHLORIDE tablets, USP CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-404-03Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET306
43547-404-10Phentermine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1006
43547-404-11Phentermine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET10006
43547-404-50Phentermine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-404-10EA - Each43547-404625abb32-9aa1-4072-b4ba-45e4e8561d2212017-09-11
43547-404-11EA - Each43547-4042d07a551-12b2-430b-ae79-a5285e46f7b512017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-404PHENTERMINE HYDROCHLORIDE TABLET [SOLCO HEALTHCARE U.S., LLC]6Current NDC, Legacy NDC, 4 package rows20250428_e4024b8a-25cb-4681-9bb4-44a38c74fe4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNe4024b8a-25cb-4681-9bb4-44a38c74fe4b6
803353phentermine hydrochloride 37.5 MG Oral TabletSCDe4024b8a-25cb-4681-9bb4-44a38c74fe4b6
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYe4024b8a-25cb-4681-9bb4-44a38c74fe4b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-404-034354704040330 TABLET in 1 BOTTLE, PLASTIC (43547-404-03) 30 tablet2002-01-040000-00-00NoNoCurrent
43547-404-1043547040410100 TABLET in 1 BOTTLE, PLASTIC (43547-404-10) 100 tablet2002-01-040000-00-00NoNoCurrent
43547-404-11435470404111000 TABLET in 1 BOTTLE, PLASTIC (43547-404-11) 1000 tablet2017-01-040000-00-00NoNoCurrent
43547-404-5043547040450500 TABLET in 1 BOTTLE, PLASTIC (43547-404-50) 500 tablet2025-04-21NoNoHistorical