FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
43063-596
11-digit product format
430630596
Labeler code
43063
Product ID
43063-596_4139a2e1-0cbe-32df-e063-6394a90a346e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040526
Marketing category
ANDA
Marketing start
2013-08-12
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
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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV

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
43063-596-01Phentermine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10024
43063-596-07Phentermine Hydrochloride7 in 1 BOTTLE, PLASTICTABLET724
43063-596-14Phentermine Hydrochloride14 in 1 BOTTLE, PLASTICTABLET1424
43063-596-15Phentermine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET1524
43063-596-21Phentermine Hydrochloride21 in 1 BOTTLE, PLASTICTABLET2124
43063-596-28Phentermine Hydrochloride28 in 1 BOTTLE, PLASTICTABLET2824
43063-596-30Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3024
43063-596-32Phentermine Hydrochloride32 in 1 BOTTLE, PLASTICTABLET3224
43063-596-42Phentermine Hydrochloride42 in 1 BOTTLE, PLASTICTABLET4224
43063-596-45Phentermine Hydrochloride45 in 1 BOTTLE, PLASTICTABLET4524
43063-596-60Phentermine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET6024
43063-596-90Phentermine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9024
43063-596-93Phentermine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET18024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-596-01EA - Each43063-596155ccc88-0754-47c1-ac22-4715ae4d226512023-02-06
43063-596-07EA - Each43063-5962816d061-813c-4e46-88a2-510d6c9c4abf12015-09-10
43063-596-14EA - Each43063-59603faabaf-213c-48e0-8b35-839ceacefb2e12015-09-10
43063-596-15EA - Each43063-596bdd006f5-173e-4bc0-b512-94c44bea651b12015-09-10
43063-596-21EA - Each43063-59627905c00-f284-4486-8953-89da765e3fb312015-09-10
43063-596-28EA - Each43063-596338fb3fb-0bde-49d4-b083-6675711368f412015-09-10
43063-596-30EA - Each43063-596f142eeaf-e41a-4e36-b656-36e00c6457e412015-09-10
43063-596-32EA - Each43063-596f28add1f-628b-43b3-84f6-8928582d848c12023-09-05
43063-596-42EA - Each43063-596a76d1272-54c6-4cc4-a21a-d158e653365f12015-09-10
43063-596-45EA - Each43063-596a998a167-6b64-48a1-94be-713771069d0b12015-09-10
43063-596-60EA - Each43063-5965234c102-d81f-47b8-a107-256e101d2f5d12015-09-10
43063-596-90EA - Each43063-5969e8bb89b-4060-419a-a6c9-04228b5da05112015-09-10
43063-596-93EA - Each43063-596c565ab76-4f87-47d5-b2d9-e4119a97bce112015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
calcium phosphate, dibasic, dihydrateINACTIVE INGREDIENTO7TSZ97GEPPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
crospovidoneINACTIVE INGREDIENT68401960MKPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
povidonesINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-596PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 13 package rows20241210_abf702d6-6f94-48dc-ad23-c52fd74e83a8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-596-0143063059601100 TABLET in 1 BOTTLE, PLASTIC (43063-596-01) 100 tablet2022-09-260000-00-00NoNoCurrent
43063-596-07430630596077 TABLET in 1 BOTTLE, PLASTIC (43063-596-07) 7 tablet2015-08-060000-00-00NoNoCurrent
43063-596-144306305961414 TABLET in 1 BOTTLE, PLASTIC (43063-596-14) 14 tablet2015-08-060000-00-00NoNoCurrent
43063-596-154306305961515 TABLET in 1 BOTTLE, PLASTIC (43063-596-15) 15 tablet2015-08-060000-00-00NoNoCurrent
43063-596-214306305962121 TABLET in 1 BOTTLE, PLASTIC (43063-596-21) 21 tablet2015-08-060000-00-00NoNoCurrent
43063-596-284306305962828 TABLET in 1 BOTTLE, PLASTIC (43063-596-28) 28 tablet2015-08-060000-00-00NoNoCurrent
43063-596-304306305963030 TABLET in 1 BOTTLE, PLASTIC (43063-596-30) 30 tablet2015-08-060000-00-00NoNoCurrent
43063-596-324306305963232 TABLET in 1 BOTTLE, PLASTIC (43063-596-32) 32 tablet2022-07-27NoNoCurrent
43063-596-424306305964242 TABLET in 1 BOTTLE, PLASTIC (43063-596-42) 42 tablet2015-08-060000-00-00NoNoCurrent
43063-596-454306305964545 TABLET in 1 BOTTLE, PLASTIC (43063-596-45) 45 tablet2015-08-060000-00-00NoNoCurrent
43063-596-604306305966060 TABLET in 1 BOTTLE, PLASTIC (43063-596-60) 60 tablet2015-08-060000-00-00NoNoCurrent
43063-596-904306305969090 TABLET in 1 BOTTLE, PLASTIC (43063-596-90) 90 tablet2015-08-060000-00-00NoNoCurrent
43063-596-9343063059693180 TABLET in 1 BOTTLE, PLASTIC (43063-596-93) 180 tablet2015-08-060000-00-00NoNoCurrent