FDA.reportPublic FDA data

Diethylpropion Hydrochloride ER

Product NDC
62135-489
11-digit product format
621350489
Labeler code
62135
Product ID
62135-489_242098aa-79fa-3372-e063-6394a90a2aaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diethylpropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA091680
Marketing category
ANDA
Marketing start
2011-10-24
Substance
DIETHYLPROPION HYDROCHLORIDE
Active strength
75 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
Diethylpropion Hydrochloride ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIETHYLPROPION HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19V2PL39NG
Rxcui978668

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
0029c986-f448-4e26-865d-441bd9700d12Product name120201013
a29cb53e-8fe0-4754-9013-e084b50c1c66Product name120170614

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-489-30Diethylpropion Hydrochloride ER30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-489-30EA - Each62135-4892b956f49-a2a4-40dd-8a17-ef6b7c9f641712023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-489DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [CHARTWELL RX, LLC.]2Current NDC, 1 package rows20241012_fdb6e69c-4f8e-42d8-bdda-c99ff3ad7c1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSNfdb6e69c-4f8e-42d8-bdda-c99ff3ad7c1e2
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCDfdb6e69c-4f8e-42d8-bdda-c99ff3ad7c1e2
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSYfdb6e69c-4f8e-42d8-bdda-c99ff3ad7c1e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-489-306213504893030 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-489-30) 2023-04-03NoNoCurrent