Rugby

Product NDC: 0536-1017
11-digit product format: 005361017
Labeler code: 0536
Product ID: 0536-1017_6a8cc572-608d-6b4a-e053-2991aa0aaa42
Type: HUMAN OTC DRUG
Nonproprietary name: Meclizine HCl
Dosage form: TABLET
Route: ORAL
Labeler: RUGBY LABORATORIES
Application: part336
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-03-07
Marketing end: 2020-01-31
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 13 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0536-1017		D	Discontinued by firm	2026-08-10
excluded package	package	0536-1017	0536-1017-01	D	Discontinued by firm	2026-08-10
excluded package	package	0536-1017	0536-1017-10	D	Discontinued by firm	2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0536-1017-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0536-1017-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0536-1017-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0536-1017-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0536-1017-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0536-1017-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0536-1017-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0536-1017-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0536-1017-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0536-1017-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0536-1017-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0536-1017-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0536-1017-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0536-1017-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0536-1017-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0536-1017-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0536-1017-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0536-1017-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0536-1017-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0536-1017-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0536-1017-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0536-1017-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0536-1017-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0536-1017-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1017-01	EA - Each	0536-1017	d858cbd4-182d-4c28-9d84-1eaca79de4b3	1	2014-11-05
0536-1017-10	EA - Each	0536-1017	f3492dff-8835-4cfb-bc54-f996b4e41627	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MECLIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	HDP7W44CIO	RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC (MECLIZINE HCL) TABLET [RUGBY LABORATORIES]	1
MECLIZINE	ACTIVE MOIETY	3L5TQ84570	RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC (MECLIZINE HCL) TABLET [RUGBY LABORATORIES]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC (MECLIZINE HCL) TABLET [RUGBY LABORATORIES]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC (MECLIZINE HCL) TABLET [RUGBY LABORATORIES]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC (MECLIZINE HCL) TABLET [RUGBY LABORATORIES]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC (MECLIZINE HCL) TABLET [RUGBY LABORATORIES]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC (MECLIZINE HCL) TABLET [RUGBY LABORATORIES]	1
SODIUM SULFATE	INACTIVE INGREDIENT	0YPR65R21J	RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC (MECLIZINE HCL) TABLET [RUGBY LABORATORIES]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC (MECLIZINE HCL) TABLET [RUGBY LABORATORIES]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HDP7W44CIO	MECLIZINE HYDROCHLORIDE	31884-77-2	MECLIZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995624	meclizine HCl 12.5 MG Oral Tablet	PSN	4fa706cc-56e7-1ed0-e054-00144ff8d46c	2
995624	meclizine hydrochloride 12.5 MG Oral Tablet	SCD	4fa706cc-56e7-1ed0-e054-00144ff8d46c	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MECLIZINE HCl, USP 12.5 mg CAPLETS	NuCare Pharmaceuticals, Inc.	2021-02-11	HUMAN OTC DRUG LABEL	2
MECLIZINE HCl, USP 12.5 mg CAPLETS	RUGBY LABORATORIES \| GEMINI PHARMACEUTICALS INC.	2018-04-23	HUMAN OTC DRUG LABEL	4
MECLIZINE HCl, USP 12.5 mg CAPLETS	A-S Medication Solutions	2018-01-09	HUMAN OTC DRUG LABEL	3
MECLIZINE HCl, USP 12.5 mg CAPLETS	Bryant Ranch Prepack	2017-05-22	HUMAN OTC DRUG LABEL	1
MECLIZINE HCl, USP 12.5 mg CAPLETS	NuCare Pharmaceuticals, Inc.	2017-05-17	HUMAN OTC DRUG LABEL	1
Rugby - RedPharm Drug, Inc. \| RedPharm Drug Inc.	RedPharm Drug, Inc. \| RedPharm Drug Inc.	2014-03-07	HUMAN OTC DRUG LABEL	2