NDC 0378-0197-05

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: 0378-0197
Requested NDC: 0378-0197-05
Package NDCs from labels: 0378-0197-05
Manufacturer: National Council for Prescription Drug Programs
Effective date: 2013-02-13
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2013-02-13	Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0197-01	EA - Each	0378-0197	705c1658-2999-4e88-b00b-270645844035	1	2012-07-24
0378-0197-05	EA - Each	0378-0197	4ae28794-a74e-4ae7-bbf0-2fa45be72791	1	2013-02-13

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 4 of 10 · 193 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Mylan Pharmaceuticals Inc.	bdbf5ad4-86f2-4e9c-a51a-fb0c7220c480	2025-11-20	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
BREYNA	BUDESONIDE AND FORMOTEROL FUMARATE	Mylan Pharmaceuticals Inc.	dc529fc4-bddb-4673-8202-dc401f86166f	2025-11-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	1533343b-f1ed-4c3a-bb36-23a748452b05	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Methylphenidate	METHYLPHENIDATE	Mylan Pharmaceuticals Inc.	1643b6a5-80da-4d4f-8c5f-feb907875702	2025-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Fenofibrate	FENOFIBRATE	Mylan Pharmaceuticals Inc.	5b67f389-55e8-466b-82bd-5ea992f630aa	2025-09-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Perphenazine and Amitriptyline Hydrochloride	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	e2937445-c015-c9a5-52f8-a2959da97290	2025-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Clozapine	CLOZAPINE	Mylan Pharmaceuticals Inc.	9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b219	2025-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Fenofibrate	FENOFIBRATE	Mylan Pharmaceuticals Inc.	0f958942-1504-40a1-8ad8-43df2c3f717e	2025-08-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Tacrolimus	TACROLIMUS	Mylan Pharmaceuticals Inc.	45af3eda-caaa-4478-9372-95aa65adc9b3	2025-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Macitentan	MACITENTAN	Mylan Pharmaceuticals Inc.	d88a13e7-cf08-4632-86be-dcd979516296	2025-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Dabigatran Etexilate	DABIGATRAN ETEXILATE	Mylan Pharmaceuticals Inc.	baafb5be-ffe6-4755-a7ab-817b3c9b222d	2025-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Carisoprodol	CARISOPRODOL	Mylan Pharmaceuticals Inc.	7c9184c0-7a2e-11df-8c8d-0002a5d5c51b	2025-07-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Scopolamine	SCOPOLAMINE	Mylan Pharmaceuticals Inc.	163accb7-45e6-4d97-844d-72b606677008	2025-07-08	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Estradiol	ESTRADIOL	Mylan Pharmaceuticals Inc.	e7e6da3b-8485-1382-61c9-e9b369018b98	2025-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Eplerenone	EPLERENONE	Mylan Pharmaceuticals Inc.	4286699b-2320-4d3d-831c-32085f36fb67	2025-06-23	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Estradiol	ESTRADIOL	Mylan Pharmaceuticals Inc.	f4efb0bf-b96f-4e20-a0f2-0806ab92b2d4	2025-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Estradiol	ESTRADIOL	Mylan Pharmaceuticals Inc.	d28bec8f-762e-4f05-a20d-96a42970d6a7	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Colestipol Hydrochloride	COLESTIPOL HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	dae7d51e-c117-4c8a-b018-45b01ae46100	2025-05-13	Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Colestipol Hydrochloride	COLESTIPOL HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	4e89bf6e-c78a-402e-9cb2-8d02f6047d68	2025-05-07	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Ticagrelor	TICAGRELOR	Mylan Pharmaceuticals Inc.	fc333c4a-ad63-4d67-a3f7-431ac469d116	2025-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.

Reported adverse events (FAERS/openFDA)#

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