Phentermine Hydrochloride

Product NDC
43063-437
11-digit product format
430630437
Labeler code
43063
Product ID
43063-437_da34054a-f466-5ff3-e053-2995a90a1a29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA200272
Marketing category
ANDA
Marketing start
2011-03-08
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
38 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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-437-07EA - Each43063-4379e1f77fb-10c0-4b2d-b280-a7ecfba38ae912013-04-01
43063-437-14EA - Each43063-43779db2bdc-089a-47a6-80a7-014f50ab939512016-06-14
43063-437-15EA - Each43063-4377bdb8c8b-fa59-4230-bdc0-ba23764c2ee912016-06-14
43063-437-21EA - Each43063-4377d565c61-4b9d-4e9a-b1d9-f1801efa615512017-06-15
43063-437-28EA - Each43063-437d7c1b41d-61fb-45da-83cc-d49abd34a72912013-04-01
43063-437-30EA - Each43063-43753c12d0c-d85c-4a8f-8e0f-2fa5395d09b912013-04-01
43063-437-45EA - Each43063-437e09ee0bf-c7e5-464f-80ee-32296bec155412013-05-02
43063-437-60EA - Each43063-43726009553-676a-4fa0-98ab-d0b97bd9887312013-05-02
43063-437-90EA - Each43063-437726e1a9a-9d24-4265-b7cb-f26a9066241112016-06-14

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
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-437PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]19Legacy NDC20250426_e5f24384-ba2a-4887-847f-779a6198dbcb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-437-07430630437077 TABLET in 1 BOTTLE, PLASTIC (43063-437-07) 7 tablet2013-02-210000-00-00NoNoCurrent
43063-437-144306304371414 TABLET in 1 BOTTLE, PLASTIC (43063-437-14) 14 tablet2013-02-210000-00-00NoNoCurrent
43063-437-154306304371515 TABLET in 1 BOTTLE, PLASTIC (43063-437-15) 15 tablet2013-02-210000-00-00NoNoCurrent
43063-437-214306304372121 TABLET in 1 BOTTLE, PLASTIC (43063-437-21) 21 tablet2013-02-210000-00-00NoNoCurrent
43063-437-284306304372828 TABLET in 1 BOTTLE, PLASTIC (43063-437-28) 28 tablet2013-02-210000-00-00NoNoCurrent
43063-437-304306304373030 TABLET in 1 BOTTLE, PLASTIC (43063-437-30) 30 tablet2013-02-210000-00-00NoNoCurrent
43063-437-424306304374242 TABLET in 1 BOTTLE, PLASTIC (43063-437-42) 42 tablet2013-02-210000-00-00NoNoCurrent
43063-437-454306304374545 TABLET in 1 BOTTLE, PLASTIC (43063-437-45) 45 tablet2013-02-210000-00-00NoNoCurrent
43063-437-604306304376060 TABLET in 1 BOTTLE, PLASTIC (43063-437-60) 60 tablet2013-02-210000-00-00NoNoCurrent
43063-437-904306304379090 TABLET in 1 BOTTLE, PLASTIC (43063-437-90) 90 tablet2013-02-210000-00-00NoNoCurrent
43063-437-9843063043798120 TABLET in 1 BOTTLE, PLASTIC (43063-437-98) 120 tablet2013-02-210000-00-00NoNoCurrent