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 9 of 10 · 187 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE DIHYDRATE	Mylan Pharmaceuticals Inc.	6c1a6c53-af85-4220-9ce3-2373e0928f7f	2020-12-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Fluvastatin Sodium	FLUVASTATIN	Mylan Pharmaceuticals Inc.	d0a7247c-5d83-4bc1-840f-c58314d14195	2020-08-20	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Candesartan Cilexetil and Hydrochlorothiazide	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	Mylan Pharmaceuticals Inc.	f3c4f7ed-e667-4528-a675-b032c2a4425d	2020-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Timolol Maleate	TIMOLOL MALEATE	Mylan Pharmaceuticals Inc.	57c62928-63d8-4505-9b9e-c085a3a12c95	2020-07-06	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Potassium Chloride	POTASSIUM CHLORIDE	Mylan Pharmaceuticals Inc.	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	2020-04-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Eletriptan Hydrobromide	ELETRIPTAN HYDROBROMIDE	Mylan Pharmaceuticals Inc.	20276f5c-f2d6-469f-9a1b-aa254a1db21c	2020-04-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Levalbuterol	LEVALBUTEROL	Mylan Pharmaceuticals Inc.	5b4fa89e-aa46-4504-a275-246f3b4df1df	2020-02-17	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Levalbuterol	LEVALBUTEROL	Mylan Pharmaceuticals Inc.	206bbdec-04f0-40e3-a259-32fc6bce20d8	2019-11-11	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Metolazone	METOLAZONE	Mylan Pharmaceuticals Inc.	6639d111-eb21-4997-b964-f5c61bc088f2	2019-10-01	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Penciclovir	PENCICLOVIR	Mylan Pharmaceuticals Inc.	9cb88c28-d9c9-45e3-b4fe-083327f122de	2019-09-04	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Halcinonide	HALCINONIDE	Mylan Pharmaceuticals Inc.	b7d78c72-a683-4208-b7dd-5523502c036c	2019-08-30	Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Ipratropium Bromide and Albuterol Sulfate	IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE	Mylan Pharmaceuticals Inc.	23c05e9a-9df5-4978-8831-cf562aa4ba92	2018-12-12	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Denavir	PENCICLOVIR	Mylan Pharmaceuticals Inc.	61229829-55a0-4d6f-a423-4b48a2b4d8e5	2018-11-26	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Telmisartan and Amlodipine	TELMISARTAN AND AMLODIPINE	Mylan Pharmaceuticals Inc.	ca60a4d5-ace7-4889-94ee-e2265fd63811	2018-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
NORETHINDRONE	NORETHINDRONE	Mylan Pharmaceuticals Inc.	af851d82-b30f-463b-9dba-0437225dc1ee	2018-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Armodafinil	ARMODAFINIL	Mylan Pharmaceuticals Inc.	de0799f7-7644-4057-a7da-75436f978c61	2018-09-17	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
VUSION	MICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUM	Mylan Pharmaceuticals Inc.	b44b452d-3630-4cb5-8ed1-1f8edac4690c	2018-08-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
VUSION	MICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUM	Mylan Pharmaceuticals Inc.	b026bc7d-3a18-41e8-88c4-1e063cd2f42c	2018-08-14	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Bepotastine Besilate	BEPOTASTINE BESILATE	Mylan Pharmaceuticals Inc.	75178670-aa57-45f9-94d5-efcf8305e683	2018-03-20	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
PRUDOXIN	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	ca53346b-8ab3-4722-98f6-cf272706d3fa	2017-06-29	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.