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 2 of 10 · 193 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	2026-06-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	4f70f907-08d5-4c2e-a4be-32c6124faa7b	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Liothyronine Sodium	LIOTHYRONINE SODIUM	Mylan Pharmaceuticals Inc.	115a84c2-0126-4dd7-816e-1873875f1e49	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Voriconazole	VORICONAZOLE	Mylan Pharmaceuticals Inc.	b8de04a0-238d-4e0b-b0d9-7f7878b149d4	2026-06-02	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Hydrocortisone	HYDROCORTISONE	Mylan Pharmaceuticals Inc.	bc751403-94f2-4f9d-b533-cf6186a40ceb	2026-05-25	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Lisdexamfetamine Dimesylate	LISDEXAMFETAMINE	Mylan Pharmaceuticals Inc.	efbde0f6-b848-4664-b741-c6c630e66108	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
medroxyprogesterone acetate	MEDROXYPROGESTERONE ACETATE	Mylan Pharmaceuticals Inc.	2627eb11-06bf-4a45-9172-094468e3ca07	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
phenelzine sulfate	PHENELZINE SULFATE	Mylan Pharmaceuticals Inc.	fa041652-fdde-4794-a8d2-279dd309e075	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Bisoprolol Fumarate and Hydrochlorothiazide	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	Mylan Pharmaceuticals Inc.	d4243a76-516c-417e-80ba-444a21ecc688	2026-05-12	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Methotrexate	METHOTREXATE	Mylan Pharmaceuticals Inc.	70c09984-2b36-424f-8b27-3fd0cd4e833d	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Mylan Pharmaceuticals Inc.	aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a	2026-04-24	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Abiraterone Acetate	ABIRATERONE ACETATE	Mylan Pharmaceuticals Inc.	fe02db79-fa04-441f-b514-70bd74af6624	2026-04-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Meclofenamate Sodium	MECLOFENAMATE SODIUM	Mylan Pharmaceuticals Inc.	96f19af4-de8f-4fd7-90d8-55fe6ebdd81d	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Difluprednate	DIFLUPREDNATE	Mylan Pharmaceuticals Inc.	4a3b2649-ee3d-4648-91c8-912a8ba2e73c	2026-04-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Clozapine	CLOZAPINE	Mylan Pharmaceuticals Inc.	883b5d43-0339-7dc1-f775-93791fb9b978	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Chlorthalidone	CHLORTHALIDONE	Mylan Pharmaceuticals Inc.	15dd224a-87ad-48dc-80b1-e8382a452c4c	2026-04-02	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Fluconazole	FLUCONAZOLE	Mylan Pharmaceuticals Inc.	737e0fac-a2d2-4053-a0d7-edbfb6248f69	2026-04-02	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Sirolimus	SIROLIMUS	Mylan Pharmaceuticals Inc.	5908cd1a-fc5a-462f-99ed-1d8983e253c9	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Sorafenib Tosylate	SORAFENIB	Mylan Pharmaceuticals Inc.	b7919013-1511-44f0-a759-3fa78a9fa178	2026-03-18	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Disopyramide Phosphate	DISOPYRAMIDE PHOSPHATE	Mylan Pharmaceuticals Inc.	31e79459-107f-4d69-a163-90014f1c4772	2026-03-18	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.