FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
53217-171
11-digit product format
532170171
Labeler code
53217
Product ID
53217-171_46e5d39c-90ed-46ae-a35a-55b32c19dce2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040555
Marketing category
ANDA
Marketing start
2005-04-15
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
53217-171-072020-01-31C16284748780-19d75b9d0-d87c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
53217-171-142020-01-31C16284748780-19d75b9d0-d87c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
53217-171-152020-01-31C16284748780-19d75b9d0-d87c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
53217-171-212020-01-31C16284748780-19d75b9d0-d87c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
53217-171-232020-01-31C16284748780-19d75b9d0-d87c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
53217-171-282020-01-31C16284748780-19d75b9d0-d87c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
53217-171-302020-01-31C16284748780-19d75b9d0-d87c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
53217-171-402020-01-31C16284748780-19d75b9d0-d87c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
53217-171-452020-01-31C16284748780-19d75b9d0-d87c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
53217-171-602020-01-31C16284748780-19d75b9d0-d87c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
53217-171-902020-01-31C16284748780-19d75b9d0-d87c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-171-07Phentermine Hydrochloride07 in 1 BOTTLETABLET071
53217-171-14Phentermine Hydrochloride14 in 1 BOTTLETABLET141
53217-171-15Phentermine Hydrochloride15 in 1 BOTTLETABLET151
53217-171-21Phentermine Hydrochloride21 in 1 BOTTLETABLET211
53217-171-23Phentermine Hydrochloride23 in 1 BOTTLETABLET231
53217-171-28Phentermine Hydrochloride28 in 1 BOTTLETABLET281
53217-171-30Phentermine Hydrochloride30 in 1 BOTTLETABLET301
53217-171-40Phentermine Hydrochloride40 in 1 BOTTLETABLET401
53217-171-45Phentermine Hydrochloride45 in 1 BOTTLETABLET451
53217-171-60Phentermine Hydrochloride60 in 1 BOTTLETABLET601
53217-171-90Phentermine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-171-07EA - Each53217-171e8f36c97-ddd6-4718-b893-e1a55053aabc12017-03-06
53217-171-14EA - Each53217-1719e863ead-0201-4a13-adf5-ad6576548c5312017-03-06
53217-171-15EA - Each53217-171583c10d3-c52e-43b8-9ca9-3014fe9e301f12017-03-06
53217-171-21EA - Each53217-171a8deee68-3265-4455-baf8-0fcddb3ce37012017-03-06
53217-171-23EA - Each53217-171e11cd341-7d1d-4000-9027-007cdd82892912017-03-06
53217-171-28EA - Each53217-171fb8f1123-0ef0-4714-a293-6ea8bf3bc59c12017-03-06
53217-171-30EA - Each53217-17170f29e1b-2388-47a6-bc8e-06d00fca755412017-03-06
53217-171-40EA - Each53217-171a62e8e31-893d-4148-b9fc-d63952af9ae812017-03-06
53217-171-45EA - Each53217-17112bfe872-ed54-4dd0-9d51-3f64651fb22e12017-03-06
53217-171-60EA - Each53217-171d6dda62e-c308-4862-8bd6-09aeca14709712017-03-06
53217-171-90EA - Each53217-171c51d56fc-c8cd-438f-8e04-30d0012869f112017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-171PHENTERMINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 11 package rows20170301_8739f879-9af6-4fd6-b8b0-12dc4fee20a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN8739f879-9af6-4fd6-b8b0-12dc4fee20a01
803353phentermine hydrochloride 37.5 MG Oral TabletSCD8739f879-9af6-4fd6-b8b0-12dc4fee20a01
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY8739f879-9af6-4fd6-b8b0-12dc4fee20a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-171-075321701710707 in 1 BOTTLEHistorical
53217-171-145321701711414 in 1 BOTTLEHistorical
53217-171-155321701711515 in 1 BOTTLEHistorical
53217-171-215321701712121 in 1 BOTTLEHistorical
53217-171-235321701712323 in 1 BOTTLEHistorical
53217-171-285321701712828 in 1 BOTTLEHistorical
53217-171-305321701713030 in 1 BOTTLEHistorical
53217-171-405321701714040 in 1 BOTTLEHistorical
53217-171-455321701714545 in 1 BOTTLEHistorical
53217-171-605321701716060 in 1 BOTTLEHistorical
53217-171-905321701719090 in 1 BOTTLEHistorical