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 5 of 10 · 193 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Mylan Pharmaceuticals Inc.	ebe34db4-816d-4f0a-adbb-826693662754	2025-04-12	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Levetiracetam	LEVETIRACETAM	Mylan Pharmaceuticals Inc.	0a987d59-560f-4650-96ec-31aec81953b5	2025-04-12	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
GABAPENTIN	GABAPENTIN	Mylan Pharmaceuticals Inc.	cff7de45-148b-4e96-88fd-6052bf75b5f7	2025-04-12	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
ILOPERIDONE	ILOPERIDONE	Mylan Pharmaceuticals Inc.	eeb0fcfd-e4e8-4fb1-9635-901dc9446235	2025-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Saxagliptin	SAXAGLIPTIN	Mylan Pharmaceuticals Inc.	6e8d8c4f-96eb-4b64-9c8c-4a5448a23a78	2025-02-28	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Alprazolam XR	ALPRAZOLAM	Mylan Pharmaceuticals Inc.	1338d1c9-7c75-42ed-95f3-9eb1b6fc51d3	2025-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Glatiramer Acetate	GLATIRAMER ACETATE	Mylan Pharmaceuticals Inc.	f38b5606-d2d7-44ec-912f-46882aa2fa7b	2025-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Glatiramer Acetate	GLATIRAMER	Mylan Pharmaceuticals Inc.	456a34c7-8511-4000-99a7-ad8f8de6d35e	2025-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Alprazolam	ALPRAZOLAM	Mylan Pharmaceuticals Inc.	13930c94-d83a-414f-be35-b1fef35f738d	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Haloperidol	HALOPERIDOL	Mylan Pharmaceuticals Inc.	c559b0b0-4087-d12a-e718-c18ccb6811e6	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Thioridazine Hydrochloride	THIORIDAZINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	56b3f4c2-52af-4947-b225-6808ae9f26f5	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	c2575a86-19e5-44df-8603-ff066bb9c9c5	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Phenytoin	PHENYTOIN	Mylan Pharmaceuticals Inc.	37943ec1-a8d2-42df-967e-6f96f84c017b	2024-12-24	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Azelastine Hydrochloride and Fluticasone Propionate	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	Mylan Pharmaceuticals Inc.	7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e	2024-12-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Glucagon	GLUCAGON	Mylan Pharmaceuticals Inc.	15b49500-0aae-4e25-9a1d-709983233cc6	2024-12-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate	EMTRICITABINE, RILPIVIRINE, TENOFOVIR DISOPROXIL FUMARATE	Mylan Pharmaceuticals Inc.	d9a4185e-43fa-4aeb-9b0f-8db01b166038	2024-12-14	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
amlodipine besylate	AMLODIPINE BESYLATE	Mylan Pharmaceuticals Inc.	180ee374-24f2-4b9c-9d54-8815f2b1dc9b	2024-11-28	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Budesonide	BUDESONIDE	Mylan Pharmaceuticals Inc.	f7265276-e649-4bc4-8ac8-1f5ac2b984e8	2024-11-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Amlodipine and atorvastatin	AMLODIPINE AND ATORVASTATIN	Mylan Pharmaceuticals Inc.	4be76756-4114-4d50-a36c-fd410f6c773d	2024-11-11	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
NITROGLYCERIN	NITROGLYCERIN	Mylan Pharmaceuticals Inc.	041f127e-5166-4484-bc1a-0a373d1187ae	2024-10-15	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.