Phentermine Hydrochloride

Product NDC
84053-027
11-digit product format
840530027
Labeler code
84053
Product ID
84053-027_3a7573b5-ad43-a080-e063-6394a90a0ef7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Martek Pharmacal Co.
Application
ANDA040886
Marketing category
ANDA
Marketing start
2024-06-01
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
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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui900038

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
84053-027-07Phentermine Hydrochloride7 in 1 BOTTLECAPSULE72
84053-027-14Phentermine Hydrochloride14 in 1 BOTTLECAPSULE142
84053-027-21Phentermine Hydrochloride21 in 1 BOTTLECAPSULE212
84053-027-28Phentermine Hydrochloride28 in 1 BOTTLECAPSULE282
84053-027-56Phentermine Hydrochloride56 in 1 BOTTLECAPSULE562

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84053-027PHENTERMINE HYDROCHLORIDE CAPSULE [MARTEK PHARMACAL CO.]1Current NDC, 5 package rows20240612_1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd2
900038phentermine hydrochloride 30 MG Oral CapsuleSCD1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd2
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84053-027-07840530027077 CAPSULE in 1 BOTTLE (84053-027-07) 7 capsule2024-06-01NoNoHistorical
84053-027-148405300271414 CAPSULE in 1 BOTTLE (84053-027-14) 14 capsule2024-06-01NoNoHistorical
84053-027-218405300272121 CAPSULE in 1 BOTTLE (84053-027-21) 21 capsule2024-06-01NoNoHistorical
84053-027-288405300272828 CAPSULE in 1 BOTTLE (84053-027-28) 28 capsule2024-06-01NoNoHistorical
84053-027-568405300275656 CAPSULE in 1 BOTTLE (84053-027-56) 56 capsule2024-06-01NoNoHistorical