FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
55289-701
11-digit product format
552890701
Labeler code
55289
Product ID
55289-701_419b433d-1cbf-6c27-e063-6294a90a155c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040876
Marketing category
ANDA
Marketing start
2012-08-15
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-701-07Phentermine Hydrochloride7 in 1 BOTTLE, PLASTICTABLET720
55289-701-14Phentermine Hydrochloride14 in 1 BOTTLE, PLASTICTABLET1420
55289-701-15Phentermine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET1520
55289-701-21Phentermine Hydrochloride21 in 1 BOTTLE, PLASTICTABLET2120
55289-701-28Phentermine Hydrochloride28 in 1 BOTTLE, PLASTICTABLET2820
55289-701-30Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3020
55289-701-32Phentermine Hydrochloride32 in 1 BOTTLE, PLASTICTABLET3220
55289-701-42Phentermine Hydrochloride42 in 1 BOTTLE, PLASTICTABLET4220
55289-701-45Phentermine Hydrochloride45 in 1 BOTTLE, PLASTICTABLET4520
55289-701-56Phentermine Hydrochloride56 in 1 BOTTLE, PLASTICTABLET5620
55289-701-60Phentermine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET6020
55289-701-90Phentermine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9020
55289-701-98Phentermine Hydrochloride120 in 1 BOTTLE, PLASTICTABLET12020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-701-07EA - Each55289-701b92f413e-45e1-4157-a70f-7e841f45322d12012-07-24
55289-701-14EA - Each55289-7017585f329-55dc-4773-9207-729b799a3b4d12012-07-24
55289-701-15EA - Each55289-7013f094762-756b-4de8-a5f3-574219b5ef3212012-07-24
55289-701-21EA - Each55289-7019da871dd-462a-4964-9f0d-7f95d2ecce8112012-07-24
55289-701-28EA - Each55289-7010a1cb7a2-5976-43e7-86ce-2947b2b760f912012-07-24
55289-701-30EA - Each55289-701b429096c-1329-4123-84fb-0f50d6ca6f9012012-07-24
55289-701-32EA - Each55289-7014ca0e617-64cd-4387-b183-c06563e30bc112015-11-12
55289-701-42EA - Each55289-701977f937e-85a4-4495-bd7a-3a7f138097f912017-03-06
55289-701-45EA - Each55289-701f4731d83-a705-4d3a-9f3b-aa844f75bb8f12012-07-24
55289-701-56EA - Each55289-70166f480e7-0b8a-46e6-822b-431877f184c812016-12-07
55289-701-60EA - Each55289-7019ea0f1d1-0596-4e1f-9528-3414d0ccc14212012-07-24
55289-701-90EA - Each55289-701aba0d72c-ba4b-4f9a-aae6-e0477a436eb012012-07-24
55289-701-98EA - Each55289-70103c07673-e661-40b1-bdc5-dc41852321c712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]4
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-701PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 13 package rows20240314_68fcc228-5f06-4ece-94f3-59b5b33c3325.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN68fcc228-5f06-4ece-94f3-59b5b33c332520
803353phentermine hydrochloride 37.5 MG Oral TabletSCD68fcc228-5f06-4ece-94f3-59b5b33c332520
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY68fcc228-5f06-4ece-94f3-59b5b33c332520

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-701-07552890701077 TABLET in 1 BOTTLE, PLASTIC (55289-701-07) 7 tablet2015-09-290000-00-00NoNoCurrent
55289-701-145528907011414 TABLET in 1 BOTTLE, PLASTIC (55289-701-14) 14 tablet2015-09-290000-00-00NoNoCurrent
55289-701-155528907011515 TABLET in 1 BOTTLE, PLASTIC (55289-701-15) 15 tablet2015-09-290000-00-00NoNoCurrent
55289-701-215528907012121 TABLET in 1 BOTTLE, PLASTIC (55289-701-21) 21 tablet2015-09-290000-00-00NoNoCurrent
55289-701-285528907012828 TABLET in 1 BOTTLE, PLASTIC (55289-701-28) 28 tablet2015-09-290000-00-00NoNoCurrent
55289-701-305528907013030 TABLET in 1 BOTTLE, PLASTIC (55289-701-30) 30 tablet2015-09-290000-00-00NoNoCurrent
55289-701-325528907013232 TABLET in 1 BOTTLE, PLASTIC (55289-701-32) 32 tablet2015-09-290000-00-00NoNoCurrent
55289-701-425528907014242 TABLET in 1 BOTTLE, PLASTIC (55289-701-42) 42 tablet2016-12-150000-00-00NoNoCurrent
55289-701-455528907014545 TABLET in 1 BOTTLE, PLASTIC (55289-701-45) 45 tablet2015-09-290000-00-00NoNoCurrent
55289-701-565528907015656 TABLET in 1 BOTTLE, PLASTIC (55289-701-56) 56 tablet2016-10-240000-00-00NoNoCurrent
55289-701-605528907016060 TABLET in 1 BOTTLE, PLASTIC (55289-701-60) 60 tablet2015-09-290000-00-00NoNoCurrent
55289-701-905528907019090 TABLET in 1 BOTTLE, PLASTIC (55289-701-90) 90 tablet2015-09-290000-00-00NoNoCurrent
55289-701-9855289070198120 TABLET in 1 BOTTLE, PLASTIC (55289-701-98) 120 tablet2016-12-150000-00-00NoNoCurrent