Meclizine Hydrochloride

Product NDC: 49884-035
11-digit product format: 498840035
Labeler code: 49884
Product ID: 49884-035_d687dbbb-40ef-4614-93e6-c20366f3607d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: meclizine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA087128
Marketing category: ANDA
Marketing start: 1981-06-03
Marketing end: 0000-00-00
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-035-01	EA - Each	49884-035	62a46d2b-5850-4125-8cee-02f2b08dc0d4	1	2012-07-24
49884-035-10	EA - Each	49884-035	c0c448f0-88c7-4282-9ec7-91ae0a7af6e3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MECLIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	HDP7W44CIO	MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
MECLIZINE	ACTIVE MOIETY	3L5TQ84570	MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	MECLIZINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
MECLIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	HDP7W44CIO	MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	2
MECLIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	HDP7W44CIO	MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
MECLIZINE	ACTIVE MOIETY	3L5TQ84570	MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	2
MECLIZINE	ACTIVE MOIETY	3L5TQ84570	MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MECLIZINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MECLIZINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	2
MECLIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	HDP7W44CIO	MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
Meclizine Hydrochloride	ACTIVE INGREDIENT	HDP7W44CIO	MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
Meclizine Hydrochloride	ACTIVE INGREDIENT	HDP7W44CIO	MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
MECLIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	HDP7W44CIO	MECLIZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
Meclizine	ACTIVE MOIETY	3L5TQ84570	MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
Meclizine	ACTIVE MOIETY	3L5TQ84570	MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MECLIZINE	ACTIVE MOIETY	3L5TQ84570	MECLIZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MECLIZINE	ACTIVE MOIETY	3L5TQ84570	MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MECLIZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MECLIZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	MECLIZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	MECLIZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MECLIZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MECLIZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MECLIZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MECLIZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MECLIZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	MECLIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MECLIZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.]	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
995666	meclizine HCl 25 MG Oral Tablet	PSN	036f8929-ad15-4bfd-96d2-c2541170500b	5
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	036f8929-ad15-4bfd-96d2-c2541170500b	5
995666	meclizine HCl 25 MG Oral Tablet	PSN	f1c072c1-5901-4c26-8ea1-c8a4c7ad570e	3
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	f1c072c1-5901-4c26-8ea1-c8a4c7ad570e	3
995624	meclizine HCl 12.5 MG Oral Tablet	PSN	68c2f8e9-3ba9-4695-af97-4ded925c060a	2
995666	meclizine HCl 25 MG Oral Tablet	PSN	68c2f8e9-3ba9-4695-af97-4ded925c060a	2
995624	meclizine hydrochloride 12.5 MG Oral Tablet	SCD	68c2f8e9-3ba9-4695-af97-4ded925c060a	2
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	68c2f8e9-3ba9-4695-af97-4ded925c060a	2
995624	meclizine HCl 12.5 MG Oral Tablet	PSN	a7839c4b-6e6e-444f-997e-2dbe28a80eaa	1
995624	meclizine HCl 12.5 MG Oral Tablet	PSN	c65aee98-bddf-4cf7-8d78-17253704b1ab	1
995666	meclizine HCl 25 MG Oral Tablet	PSN	a7839c4b-6e6e-444f-997e-2dbe28a80eaa	1
995666	meclizine HCl 25 MG Oral Tablet	PSN	c65aee98-bddf-4cf7-8d78-17253704b1ab	1
995666	meclizine HCl 25 MG Oral Tablet	PSN	e6aa2220-2ef7-41d0-870d-e898ebcb4e7f	1
995666	meclizine HCl 25 MG Oral Tablet	PSN	020b7dd4-c270-4046-97f2-c646ce067168	1
995624	meclizine hydrochloride 12.5 MG Oral Tablet	SCD	c65aee98-bddf-4cf7-8d78-17253704b1ab	1
995624	meclizine hydrochloride 12.5 MG Oral Tablet	SCD	a7839c4b-6e6e-444f-997e-2dbe28a80eaa	1
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	020b7dd4-c270-4046-97f2-c646ce067168	1
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	a7839c4b-6e6e-444f-997e-2dbe28a80eaa	1
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	c65aee98-bddf-4cf7-8d78-17253704b1ab	1
995666	meclizine hydrochloride 25 MG Oral Tablet	SCD	e6aa2220-2ef7-41d0-870d-e898ebcb4e7f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-035-01	49884003501	100 TABLET in 1 BOTTLE (49884-035-01)	100 tablet	1981-06-03	0000-00-00	No	No	Current
49884-035-10	49884003510	1000 TABLET in 1 BOTTLE (49884-035-10)	1000 tablet	1981-06-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rx Only	Unit Dose Services	2017-11-07	HUMAN PRESCRIPTION DRUG LABEL	5
MECLIZINE HYDROCHLORIDE tablet	Blenheim Pharmacal, Inc.	2014-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
MECLIZINE FOR PAR	Liberty Pharmaceuticals, Inc.	2013-09-10	HUMAN PRESCRIPTION DRUG LABEL	1
MECLIZINE HYDROCHLORIDE - STAT Rx USA LLC \| PSS World Medical Inc.	STAT Rx USA LLC \| PSS World Medical Inc.	2012-09-20	HUMAN PRESCRIPTION DRUG LABEL	2
Meclizine Hydrochloride	Rebel Distributors Corp.	2010-09-15	HUMAN PRESCRIPTION DRUG LABEL	1
Meclizine Hydrochloride	Physicians Total Care, Inc.	2010-09-15	HUMAN PRESCRIPTION DRUG LABEL	1
Meclizine Hydrochloride - State of Florida DOH Central Pharmacy	State of Florida DOH Central Pharmacy	2010-05-26	HUMAN PRESCRIPTION DRUG LABEL	1

Meclizine Hydrochloride

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#