FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
84053-910
11-digit product format
840530910
Labeler code
84053
Product ID
84053-910_48fd28f6-101b-498c-e063-6294a90aba52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Martek Pharmacal Co.
Application
ANDA202248
Marketing category
ANDA
Marketing start
2024-02-12
Marketing end
2028-04-29
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride

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
84053-910-07Phentermine Hydrochloride7 in 1 BOTTLECAPSULE78
84053-910-14Phentermine Hydrochloride14 in 1 BOTTLECAPSULE148
84053-910-21Phentermine Hydrochloride21 in 1 BOTTLECAPSULE218

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84053-910PHENTERMINE HYDROCHLORIDE CAPSULE [MARTEK PHARMACAL CO.]6Current NDC, 3 package rows20240718_1149f69d-65df-6a98-e063-6394a90aeaa4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN1149f69d-65df-6a98-e063-6394a90aeaa48
900038phentermine hydrochloride 30 MG Oral CapsuleSCD1149f69d-65df-6a98-e063-6394a90aeaa48
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY1149f69d-65df-6a98-e063-6394a90aeaa48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
84053-910-07840530910077 CAPSULE in 1 BOTTLE (84053-910-07) 7 capsule2026-01-222028-04-29NoNoHistorical
84053-910-148405309101414 CAPSULE in 1 BOTTLE (84053-910-14) 14 capsule2026-01-222028-04-29NoNoHistorical
84053-910-218405309102121 CAPSULE in 1 BOTTLE (84053-910-21) 21 capsule2024-06-112028-04-29NoNoHistorical