NDC 68071-3837-01 - Diethylpropion Hydrochloride ER

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68071-3837
Requested NDC: 68071-3837-01
Package NDCs from labels: 68071-3837-1, 68071-3837-01
Manufacturer: NuCare Pharmaceuticals, Inc.
Effective date: 2025-04-21
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only	NuCare Pharmaceuticals, Inc.	2025-04-21	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3837-1	Diethylpropion HydrochlorideER	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3837	DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS, INC.]	1	Current NDC, 1 package rows	20250423_335265e0-1d5d-31fb-e063-6394a90a2e75.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fe7e5022-8b58-aa4f-e053-6294a90af65e	2025-02-04	Warnings, Adverse reactions	Exact identifier unii: 19V2PL39NG
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	A-S Medication Solutions	7f4eca5b-f850-44fc-88b4-4d9bcdf2ba44	2025-01-22	Warnings, Adverse reactions	Exact identifier unii: 19V2PL39NG
DIETHYLPROPION HYDROCHLORIDE ER	DIETHYLPROPION HYDROCHLORIDE ER	Directrx	d44e23db-381a-cfc3-e053-2995a90a13c8	2025-01-21	Warnings, Adverse reactions	Exact identifier application number: ANDA091680 rxcui: 978668 unii: 19V2PL39NG
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	Chartwell RX, LLC.	b8984c2d-244e-4c56-be3e-c402dc679b1f	2024-10-10	Warnings, Adverse reactions	Exact identifier unii: 19V2PL39NG
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	Chartwell RX, LLC.	fdb6e69c-4f8e-42d8-bdda-c99ff3ad7c1e	2024-10-10	Warnings, Adverse reactions	Exact identifier application number: ANDA091680 rxcui: 978668 unii: 19V2PL39NG
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	Bryant Ranch Prepack	54655904-7ce2-49d5-9acf-81ad9680d215	2024-10-02	Warnings, Adverse reactions	Exact identifier unii: 19V2PL39NG
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	Bryant Ranch Prepack	fb8e2f1b-24ef-4e1d-a493-4c3b3de05b26	2024-08-07	Warnings, Adverse reactions	Exact identifier unii: 19V2PL39NG
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	Bryant Ranch Prepack	89306917-a65b-40d4-9c51-d59ac0ad2017	2024-08-07	Warnings, Adverse reactions	Exact identifier application number: ANDA091680 rxcui: 978668 unii: 19V2PL39NG
DIETHYLPROPION HYDROCHLORIDE	DIETHYLPROPION HYDROCHLORIDE	KVK-TECH, INC	3ecb7bd7-e04c-47fe-859a-8ba8a54f9aff	2024-05-01	Warnings, Adverse reactions	Exact identifier unii: 19V2PL39NG
MANNITOL	MANNITOL	HF Acquisition Co LLC, DBA HealthFirst	999ce711-2d5b-0d7d-e053-2995a90a2689	2024-01-27	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
D02 DIGESTIVE DRAINAGE	ALOE, ACTIVATED CHARCOAL, COLCHICUM AUTUMNALE BULB, COLLINSONIA CANADENSIS ROOT, CUCURBITA PEPO FLOWER, DRYOPTERIS FILIX-MAS ROOT, INDOLE, SKIM MILK, LYCOPODIUM CLAVATUM SPORE, ACHILLEA MILLEFOLIUM, SODIUM SULFATE, FRANGULA PURSHIANA BARK, SCROPHULARIA NODOSA, SKATOLE, TARAXACUM OFFICINALE, TARTARIC ACID	Apex Energetics Inc.	ba8734bf-920c-0ce4-e053-2a95a90a0705	2024-01-08	Warnings	Exact identifier unii: W4888I119H
Mannitol	MANNITOL	B. Braun Medical Inc.	d12cc802-b538-4065-a264-f474ff3b3043	2023-08-15	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
Mannitol	MANNITOL	Fresenius Kabi USA, LLC	c395e13d-6ea1-4104-8b37-669cfb982f04	2023-03-16	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	Lannett Company, Inc.	dab53f4f-68d4-4477-a2b6-ad44a956332b	2022-07-27	Warnings, Adverse reactions	Exact identifier application number: ANDA091680 ndc (product): 0527-1477 rxcui: 978668 spl id: 425fc6fb-0240-4af6-83e4-3c7cb54c50e3 spl set id: dab53f4f-68d4-4477-a2b6-ad44a956332b unii: 19V2PL39NG
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	Proficient Rx LP	2a2fbc1b-6430-485b-b581-10fbfca0af88	2020-10-01	Warnings, Adverse reactions	Exact identifier unii: 19V2PL39NG
Diethylpropion Hydrochloride	DIETHYLPROPION HYDROCHLORIDE	Lannett Company, Inc.	4fdbc049-6497-4ea0-8788-d2b2963328f7	2019-12-31	Warnings, Adverse reactions	Exact identifier unii: 19V2PL39NG
Diethylpropion Hydrochloride ER	DIETHYLPROPION HYDROCHLORIDE	Proficient Rx LP	15110f70-6602-4e05-a4b5-716a86dcaed5	2019-11-01	Warnings, Adverse reactions	Exact identifier application number: ANDA091680 rxcui: 978668 unii: 19V2PL39NG

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.