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 3 of 10 · 193 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlordiazepoxide and Amitriptyline Hydrochloride	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	66a756f2-ac77-451c-a19a-08896d73b15c	2026-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Albuterol	ALBUTEROL	Mylan Pharmaceuticals Inc.	9e6e982b-7dfe-45b8-aa76-754e8d2a8ef6	2026-03-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Spironolactone	SPIRONOLACTONE	Mylan Pharmaceuticals Inc.	beaf74db-4159-3b59-ef99-575c3ac99aa1	2026-03-12	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Spironolactone and Hydrochlorothiazide	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	Mylan Pharmaceuticals Inc.	0c8c973f-13a2-4883-8316-4006398e2931	2026-03-11	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Mylan Pharmaceuticals Inc.	83bcc2fb-6fb0-4f0e-8e66-592d327684ec	2026-02-23	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Valacyclovir Hydrochloride	VALACYCLOVIR	Mylan Pharmaceuticals Inc.	56bf715d-8280-4557-9f98-9693932199e5	2026-02-16	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Voriconazole	VORICONAZOLE	Mylan Pharmaceuticals Inc.	67c174da-41b8-4738-8a22-dd814b8e96b8	2026-02-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Atenolol	ATENOLOL	Mylan Pharmaceuticals Inc.	a7048c81-6769-436b-8397-fbaa7489fcdf	2026-02-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Estradiol	ESTRADIOL	Mylan Pharmaceuticals Inc.	98770987-b313-4f2a-9aac-db0ab2068cc6	2026-02-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Mylan Pharmaceuticals Inc.	89dd7e24-85fc-4152-89ea-47ec2b48a1ed	2026-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Albuterol Sulfate	ALBUTEROL SULFATE	Mylan Pharmaceuticals Inc.	5329614f-ae0b-4854-bb6f-ea0b7dae87c0	2026-02-10	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Buprenorphine and Naloxone	BUPRENORPHINE AND NALOXONE	Mylan Pharmaceuticals Inc.	557d8d4d-8751-431c-b18e-9d5cf23fc579	2026-01-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	b94dcec7-7633-4a33-9cea-48161adeaf93	2026-01-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Travoprost Ophthalmic Solution, 0.004%	TRAVOPROST OPHTHALMIC SOLUTION, 0.004%	Mylan Pharmaceuticals Inc.	00dc284f-fd96-423b-bb8f-b90ee13439bf	2026-01-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
SILVER SULFADIAZINE	SILVER SULFADIAZINE	Mylan Pharmaceuticals Inc.	7a6a9590-9983-46ff-ae5c-fe95f4e16cb8	2025-12-26	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
EXEMESTANE	EXEMESTANE	Mylan Pharmaceuticals Inc.	69abd0ff-b200-4d1a-b14a-80e980a8e781	2025-12-24	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	2025-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Mylan Pharmaceuticals Inc.	f7480256-8b32-419a-8983-e2c413040dba	2025-12-12	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Ambrisentan	AMBRISENTAN	Mylan Pharmaceuticals Inc.	8080b009-361b-4505-b09a-0d91a0e4a2c0	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	ec7e93b8-666c-4d2f-8d08-07931e09f748	2025-11-27	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.