FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
52959-812
11-digit product format
529590812
Labeler code
52959
Product ID
52959-812_61e4300d-6f7e-6951-e053-2a91aa0a974a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA203068
Marketing category
ANDA
Marketing start
2017-07-18
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
2019-12-31
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
52959-812-212020-01-31C16284748780-19d75b9d0-4312-f424-e053-dadaa90a57ce5486d426-4704-0bed-e054-00144ff8d46c
52959-812-452020-01-31C16284748780-19d75b9d0-4312-f424-e053-dadaa90a57ce5486d426-4704-0bed-e054-00144ff8d46c
52959-812-072019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-102019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-112019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-142019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-202019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-222019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-282019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-302019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-602019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
52959-812-902019-11-13C16284748780-197449f38-b8ca-f6ea-e053-dbdaa90aa703PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-812-07Phentermine Hydrochloride7 in 1 BOTTLETABLET72
52959-812-10Phentermine Hydrochloride10 in 1 BOTTLETABLET102
52959-812-11Phentermine Hydrochloride11 in 1 BOTTLETABLET112
52959-812-14Phentermine Hydrochloride14 in 1 BOTTLETABLET142
52959-812-20Phentermine Hydrochloride20 in 1 BOTTLETABLET202
52959-812-21Phentermine Hydrochloride21 in 1 BOTTLETABLET212
52959-812-22Phentermine Hydrochloride22 in 1 BOTTLETABLET222
52959-812-28Phentermine Hydrochloride28 in 1 BOTTLETABLET282
52959-812-30Phentermine Hydrochloride30 in 1 BOTTLETABLET302
52959-812-45Phentermine Hydrochloride45 in 1 CONTAINERTABLET452
52959-812-60Phentermine Hydrochloride60 in 1 BOTTLETABLET602
52959-812-90Phentermine Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-812-07EA - Each52959-812100113a3-fcfb-4f27-b704-5d15323757e712012-07-24
52959-812-10EA - Each52959-812f8d66d7e-77a1-4806-bc7f-5c4cd1bb161b12012-07-24
52959-812-11EA - Each52959-812adde597c-c9a7-4739-b969-36e2862cc69412012-07-24
52959-812-14EA - Each52959-812ec7e123b-e78b-4269-8f7d-203520f3483812012-07-24
52959-812-20EA - Each52959-812f0cbdd02-2245-4c74-a59e-221158df535512012-07-24
52959-812-22EA - Each52959-81265eb80fa-60e5-428f-806a-1632223654eb12012-07-24
52959-812-30EA - Each52959-812b76a984e-d02a-4c5c-97d1-fda566361cfe12012-07-24
52959-812-60EA - Each52959-81298fbdcb9-6fa9-432b-ba11-add088b14b6012012-07-24
52959-812-90EA - Each52959-81282da4eb5-04d2-4b06-81f7-db0f6475139112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-812PHENTERMINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 2 package rows20180103_5486d426-4704-0bed-e054-00144ff8d46c.zip
52959-812PHENTERMINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 10 package rows20111230_a894c87a-f04d-4080-a52b-b3fd8b8b6e01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN5486d426-4704-0bed-e054-00144ff8d46c2
803353phentermine HCl 37.5 MG Oral TabletPSNa894c87a-f04d-4080-a52b-b3fd8b8b6e012
803353phentermine hydrochloride 37.5 MG Oral TabletSCD5486d426-4704-0bed-e054-00144ff8d46c2
803353phentermine hydrochloride 37.5 MG Oral TabletSCDa894c87a-f04d-4080-a52b-b3fd8b8b6e012
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY5486d426-4704-0bed-e054-00144ff8d46c2
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYa894c87a-f04d-4080-a52b-b3fd8b8b6e012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-812-07529590812077 in 1 BOTTLEHistorical
52959-812-105295908121010 in 1 BOTTLEHistorical
52959-812-115295908121111 in 1 BOTTLEHistorical
52959-812-145295908121414 in 1 BOTTLEHistorical
52959-812-205295908122020 in 1 BOTTLEHistorical
52959-812-215295908122121 in 1 BOTTLEHistorical
52959-812-225295908122222 in 1 BOTTLEHistorical
52959-812-285295908122828 in 1 BOTTLEHistorical
52959-812-305295908123030 in 1 BOTTLEHistorical
52959-812-455295908124545 in 1 CONTAINERHistorical
52959-812-605295908126060 in 1 BOTTLEHistorical
52959-812-905295908129090 in 1 BOTTLEHistorical