NDC 67296-1077-01 - Orphenadrine Citrate

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: 67296-1077
Requested NDC: 67296-1077-01
Package NDCs from labels: 67296-1077-1, 67296-1077-01
Manufacturer: RedPharm Drug
Effective date: 2024-07-11
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Orphenadrine Citrate - RedPharm Drug	RedPharm Drug	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1077-1	Orphenadrine Citrate	10 in 1 BOTTLE	TABLET, EXTENDED RELEASE	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1077	ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [REDPHARM DRUG]	1	Current NDC, 1 package rows	20240712_1cff761d-e594-a9e6-e063-6394a90a1fd5.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 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orphenadrine Citrate	ORPHENADRINE CITRATE	Sandoz Inc	239018ff-cec6-46de-ae9d-26c9ec034a32	2024-03-22	Warnings, Adverse reactions	Exact identifier application number: ANDA040327 ndc (product): 0185-0022 rxcui: 994521 spl id: de0e8cdb-788a-4ebe-969d-14d44a14ddc2 spl set id: 239018ff-cec6-46de-ae9d-26c9ec034a32 unii: X0A40N8I4S
Orphenadrine Citrate	ORPHENADRINE CITRATE	Proficient Rx LP	cf620257-7497-44c1-9853-87f96d262fbd	2023-12-01	Warnings, Adverse reactions	Exact identifier rxcui: 994521 unii: X0A40N8I4S
Orphenadrine Citrate	ORPHENADRINE CITRATE	Sagent Pharmaceuticals	c8d8596a-b81f-4b83-a2f3-a55922ca4a82	2023-11-14	Warnings, Adverse reactions	Exact identifier unii: X0A40N8I4S
Orphenadrine Citrate	ORPHENADRINE CITRATE	Proficient Rx LP	37e6a157-5d0d-4887-9a26-ed5521fb08e6	2019-11-01	Warnings, Adverse reactions	Exact identifier application number: ANDA040327 rxcui: 994521 unii: X0A40N8I4S
Orphenadrine Citrate	ORPHENADRINE CITRATE	Actavis Pharma, Inc.	aec8ad3a-f717-4e74-b7b9-19debdaad79a	2016-07-20	Warnings, Adverse reactions	Exact identifier unii: X0A40N8I4S

Reported adverse events (FAERS/openFDA)#

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