Phentermine Hydrochloride

Product NDC
21695-510
11-digit product format
216950510
Labeler code
21695
Product ID
21695-510_7f871c5e-02e5-40f3-a60d-c9d2e9f5ce66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA087022
Marketing category
ANDA
Marketing start
1983-02-03
Marketing end
0000-00-00
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-510-302019-09-24C16284748780-1934fe258-4b9f-48b1-e053-8cdaa90a720aPHENTERMINE HYDROCHLORIDE CAPSULES, USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-510-30Phentermine Hydrochloride30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-510-30EA - Each21695-510223ad747-653a-404b-a9fb-da89e3e45aff12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
gelatinINACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-510PHENTERMINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101201_7f871c5e-02e5-40f3-a60d-c9d2e9f5ce66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN7f871c5e-02e5-40f3-a60d-c9d2e9f5ce661
900038phentermine hydrochloride 30 MG Oral CapsuleSCD7f871c5e-02e5-40f3-a60d-c9d2e9f5ce661
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY7f871c5e-02e5-40f3-a60d-c9d2e9f5ce661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-510-302169505103030 in 1 BOTTLEHistorical