FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
71335-2488
11-digit product format
713352488
Labeler code
71335
Product ID
71335-2488_6738a0d7-aab6-4c1a-8d28-efa24860f432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200272
Marketing category
ANDA
Marketing start
2024-02-15
Marketing end
2028-04-30
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
37.5 mg/1
Pharmacologic classes
Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui803353

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
71335-2488-0Phentermine Hydrochloride90 in 1 BOTTLETABLET902
71335-2488-1Phentermine Hydrochloride30 in 1 BOTTLETABLET302
71335-2488-2Phentermine Hydrochloride15 in 1 BOTTLETABLET152
71335-2488-3Phentermine Hydrochloride28 in 1 BOTTLETABLET282
71335-2488-4Phentermine Hydrochloride7 in 1 BOTTLETABLET72
71335-2488-5Phentermine Hydrochloride14 in 1 BOTTLETABLET142
71335-2488-6Phentermine Hydrochloride60 in 1 BOTTLETABLET602
71335-2488-7Phentermine Hydrochloride45 in 1 BOTTLETABLET452
71335-2488-8Phentermine Hydrochloride2 in 1 BOTTLETABLET22
71335-2488-9Phentermine Hydrochloride21 in 1 BOTTLETABLET212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2488-0EA - Each71335-2488ed0d1883-4ea4-4c66-a58e-f44d374c803b12025-08-11
71335-2488-1EA - Each71335-2488cf9ac624-e5e8-4a4f-b44e-9a98d6d528f812025-08-11
71335-2488-3EA - Each71335-2488b9ba23aa-22d2-48ee-8d97-f290783580b712025-08-11
71335-2488-4EA - Each71335-2488890eada5-1264-4b8d-9516-5d5123bd005112025-08-11
71335-2488-6EA - Each71335-248826938f6a-a3cf-498e-8a2a-78419796e22c12025-08-11
71335-2488-7EA - Each71335-248885f27816-efa1-4471-931e-425ab2c412f312025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2488PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1Current NDC, 10 package rows20240920_e6939fcf-3db2-492a-99ed-a384cdeea7a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNe6939fcf-3db2-492a-99ed-a384cdeea7a22
803353phentermine hydrochloride 37.5 MG Oral TabletSCDe6939fcf-3db2-492a-99ed-a384cdeea7a22
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYe6939fcf-3db2-492a-99ed-a384cdeea7a22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2488-07133524880090 TABLET in 1 BOTTLE (71335-2488-0) 90 tablet2024-09-182028-04-30NoNoHistorical
71335-2488-17133524880130 TABLET in 1 BOTTLE (71335-2488-1) 30 tablet2024-09-182028-04-30NoNoHistorical
71335-2488-27133524880215 TABLET in 1 BOTTLE (71335-2488-2) 15 tablet2024-09-182028-04-30NoNoHistorical
71335-2488-37133524880328 TABLET in 1 BOTTLE (71335-2488-3) 28 tablet2024-09-182028-04-30NoNoHistorical
71335-2488-4713352488047 TABLET in 1 BOTTLE (71335-2488-4) 7 tablet2024-09-182028-04-30NoNoHistorical
71335-2488-57133524880514 TABLET in 1 BOTTLE (71335-2488-5) 14 tablet2024-09-182028-04-30NoNoHistorical
71335-2488-67133524880660 TABLET in 1 BOTTLE (71335-2488-6) 60 tablet2024-09-182028-04-30NoNoHistorical
71335-2488-77133524880745 TABLET in 1 BOTTLE (71335-2488-7) 45 tablet2024-09-182028-04-30NoNoHistorical
71335-2488-8713352488082 TABLET in 1 BOTTLE (71335-2488-8) 2 tablet2024-09-182028-04-30NoNoHistorical
71335-2488-97133524880921 TABLET in 1 BOTTLE (71335-2488-9) 21 tablet2024-09-182028-04-30NoNoHistorical