FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
71205-564
11-digit product format
712050564
Labeler code
71205
Product ID
71205-564_39d7a8f2-00e7-4629-8e93-7175f047e331
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA205019
Marketing category
ANDA
Marketing start
2017-01-24
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
15 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui968766

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
71205-564-07Phentermine Hydrochloride7 in 1 BOTTLECAPSULE72
71205-564-15Phentermine Hydrochloride15 in 1 BOTTLECAPSULE152
71205-564-30Phentermine Hydrochloride30 in 1 BOTTLECAPSULE302
71205-564-60Phentermine Hydrochloride60 in 1 BOTTLECAPSULE602
71205-564-90Phentermine Hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-564-30EA - Each71205-564961745af-030e-44cc-8807-ab270f27c83712021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-564PHENTERMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 5 package rows20220409_5c1f88ba-d7d6-4b48-b951-c5e65d87e874.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN5c1f88ba-d7d6-4b48-b951-c5e65d87e8742
968766phentermine hydrochloride 15 MG Oral CapsuleSCD5c1f88ba-d7d6-4b48-b951-c5e65d87e8742
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY5c1f88ba-d7d6-4b48-b951-c5e65d87e8742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-564-07712050564077 CAPSULE in 1 BOTTLE (71205-564-07) 7 capsule2021-05-100000-00-00NoNoCurrent
71205-564-157120505641515 CAPSULE in 1 BOTTLE (71205-564-15) 15 capsule2021-05-100000-00-00NoNoCurrent
71205-564-307120505643030 CAPSULE in 1 BOTTLE (71205-564-30) 30 capsule2021-05-100000-00-00NoNoCurrent
71205-564-607120505646060 CAPSULE in 1 BOTTLE (71205-564-60) 60 capsule2021-05-100000-00-00NoNoCurrent
71205-564-907120505649090 CAPSULE in 1 BOTTLE (71205-564-90) 90 capsule2021-05-100000-00-00NoNoCurrent