Haloperidol Tablets, USP

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-30
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-05-31 21:18:23

Label at a glance#

ProductHaloperidol

Active ingredientHALOPERIDOL

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-837-01 in bottle of 100 Tablets

Haloperidol Tablets USP, 0.5 mg

Rx only

100 Tablets

NDC 65841-838-01 in bottle of 100 Tablets

Haloperidol Tablets USP, 1 mg

Rx only

100 Tablets

NDC 65841-839-01 in bottle of 100 Tablets

Haloperidol Tablets USP, 2 mg

Rx only

100 Tablets

NDC 65841-626-01 in bottle of 100 Tablets

Haloperidol Tablets USP, 5 mg

Rx only

100 Tablets

NDC 65841-627-01 in bottles of 100 tablets

Haloperidol Tablets USP, 10 mg

R_x only

100 Tablets

NDC 65841-628-01 in bottles of 100 tablets

Haloperidol Tablets USP, 20 mg

R_x only

100 Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310670	haloperidol 0.5 MG Oral Tablet	PSN	8
310671	haloperidol 1 MG Oral Tablet	PSN	8
314035	haloperidol 10 MG Oral Tablet	PSN	8
314034	haloperidol 2 MG Oral Tablet	PSN	8
197754	haloperidol 20 MG Oral Tablet	PSN	8
310672	haloperidol 5 MG Oral Tablet	PSN	8
310670	haloperidol 0.5 MG Oral Tablet	SCD	8
310671	haloperidol 1 MG Oral Tablet	SCD	8
314035	haloperidol 10 MG Oral Tablet	SCD	8
314034	haloperidol 2 MG Oral Tablet	SCD	8
197754	haloperidol 20 MG Oral Tablet	SCD	8
310672	haloperidol 5 MG Oral Tablet	SCD	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
HALOPERIDOL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d599bae4-cb25-0798-7468-31aa188fb750	Product name	7	20260304
6aae29ef-bf3c-3ebb-3bf1-10ee5424a22e	Product name	2	20250114
af58e43a-5792-c2c1-8e57-a2454df1f2c0	Product name	3	20240202
ce329990-eb12-45a5-87d5-ce5ef054ca71	Product name	2	20190930

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65841-626-01	Haloperidol	100 in 1 BOTTLE	TABLET	100	8
65841-626-10	Haloperidol	1000 in 1 BOTTLE	TABLET	1000	8
65841-627-01	Haloperidol	100 in 1 BOTTLE	TABLET	100	8
65841-627-10	Haloperidol	1000 in 1 BOTTLE	TABLET	1000	8
65841-628-01	Haloperidol	100 in 1 BOTTLE	TABLET	100	8
65841-628-06	Haloperidol	30 in 1 BOTTLE	TABLET	30	8
65841-837-01	Haloperidol	100 in 1 BOTTLE	TABLET	100	8
65841-837-10	Haloperidol	1000 in 1 BOTTLE	TABLET	1000	8
65841-837-30	Haloperidol	10 in 1 BLISTER PACK	TABLET	10	8
65841-837-77	Haloperidol	10 in 1 CARTON	TABLET	10	8
65841-838-01	Haloperidol	100 in 1 BOTTLE	TABLET	100	8
65841-838-10	Haloperidol	1000 in 1 BOTTLE	TABLET	1000	8
65841-838-30	Haloperidol	10 in 1 BLISTER PACK	TABLET	10	8
65841-838-77	Haloperidol	10 in 1 CARTON	TABLET	10	8
65841-839-01	Haloperidol	100 in 1 BOTTLE	TABLET	100	8
65841-839-10	Haloperidol	1000 in 1 BOTTLE	TABLET	1000	8
65841-839-30	Haloperidol	10 in 1 BLISTER PACK	TABLET	10	8
65841-839-77	Haloperidol	10 in 1 CARTON	TABLET	10	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-626	HALOPERIDOL TABLET [ZYDUS LIFESCIENCES LIMITED]	8	Current NDC, Legacy NDC, 2 package rows	20241201_509d0eb2-b930-4836-9669-dbebf0ac4076.zip
65841-627	HALOPERIDOL TABLET [ZYDUS LIFESCIENCES LIMITED]	8	Current NDC, Legacy NDC, 2 package rows	20241201_509d0eb2-b930-4836-9669-dbebf0ac4076.zip
65841-628	HALOPERIDOL TABLET [ZYDUS LIFESCIENCES LIMITED]	8	Current NDC, Legacy NDC, 2 package rows	20241201_509d0eb2-b930-4836-9669-dbebf0ac4076.zip
65841-837	HALOPERIDOL TABLET [ZYDUS LIFESCIENCES LIMITED]	8	Current NDC, 4 package rows	20241201_509d0eb2-b930-4836-9669-dbebf0ac4076.zip
65841-838	HALOPERIDOL TABLET [ZYDUS LIFESCIENCES LIMITED]	8	Current NDC, 4 package rows	20241201_509d0eb2-b930-4836-9669-dbebf0ac4076.zip
65841-839	HALOPERIDOL TABLET [ZYDUS LIFESCIENCES LIMITED]	8	Current NDC, 4 package rows	20241201_509d0eb2-b930-4836-9669-dbebf0ac4076.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HALOPERIDOL	ACTIVE INGREDIENT	J6292F8L3D	1
HALOPERIDOL	ACTIVE MOIETY	J6292F8L3D	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

Haloperidol
ALUMINUM OXIDE
CALCIUM STEARATE
D&C YELLOW NO. 10
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 1 ALUMINUM LAKE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
D&C RED NO. 27 ALUMINUM LAKE
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65841-626	65841-626-01, 65841-626-10
65841-627	65841-627-01, 65841-627-10
65841-628	65841-628-01, 65841-628-06
65841-837	65841-837-01, 65841-837-10, 65841-837-30, 65841-837-77
65841-838	65841-838-01, 65841-838-10, 65841-838-30, 65841-838-77
65841-839	65841-839-01, 65841-839-10, 65841-839-30, 65841-839-77

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HALOPERIDOL	J6292F8L3D	ACTIB
ALUMINUM OXIDE	LMI26O6933	IACT
CALCIUM STEARATE	776XM7047L	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	IACT
FD&C BLUE NO. 1 ALUMINUM LAKE	J9EQA3S2JM	IACT
POVIDONE K30	U725QWY32X	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT
HALOPERIDOL	J6292F8L3D	ACTIB
CALCIUM STEARATE	776XM7047L	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	IACT
FD&C BLUE NO. 1 ALUMINUM LAKE	J9EQA3S2JM	IACT
POVIDONE K30	U725QWY32X	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
HALOPERIDOL	J6292F8L3D	ACTIB
CALCIUM STEARATE	776XM7047L	IACT
D&C RED NO. 27 ALUMINUM LAKE	ZK64F7XSTX	IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
POVIDONE K30	U725QWY32X	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT
HALOPERIDOL	J6292F8L3D	ACTIB
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE 102	PNR0YF693Y	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
HALOPERIDOL	J6292F8L3D	ACTIB
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE 102	PNR0YF693Y	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
HALOPERIDOL	J6292F8L3D	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 192 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL		2442 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL		2442 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / ORAL		2828 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / ORAL		2828 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / ORAL		2828 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
CALCIUM STEARATE	CALCIUM STEARATE	776XM7047L	TABLET / ORAL		280 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / ORAL		2828 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
CALCIUM STEARATE	CALCIUM STEARATE	776XM7047L	TABLET / ORAL		280 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / ORAL		2828 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / ORAL		2828 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL		2442 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
CALCIUM STEARATE	CALCIUM STEARATE	776XM7047L	TABLET / ORAL		280 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
CALCIUM STEARATE	CALCIUM STEARATE	776XM7047L	TABLET / ORAL		280 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / ORAL		2828 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
CALCIUM STEARATE	CALCIUM STEARATE	776XM7047L	TABLET / ORAL		280 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
CALCIUM STEARATE	CALCIUM STEARATE	776XM7047L	TABLET / ORAL		280 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
CALCIUM STEARATE	CALCIUM STEARATE	776XM7047L	TABLET / ORAL		280 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL		2442 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / ORAL		2828 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / ORAL		2828 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
CALCIUM STEARATE	CALCIUM STEARATE	776XM7047L	TABLET / ORAL		280 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
D&C RED NO. 27	D&C RED NO. 27	2LRS185U6K	TABLET / ORAL		1 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL		2442 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077580-001	HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17
A077580-002	HALOPERIDOL	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17
A077580-003	HALOPERIDOL	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29
A077580-004	HALOPERIDOL	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29
A077580-005	HALOPERIDOL	HALOPERIDOL	20MG	TABLET / ORAL	AB		2007-11-29
A077580-006	HALOPERIDOL	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	2023-01-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A077580-001	AB
A077580-002	AB
A077580-003	AB
A077580-004	AB
A077580-005	AB
A077580-006	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB		2007-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	2023-01-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB		2007-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	2023-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB		2007-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB		2023-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB		2007-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB		2023-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB		2007-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB		2023-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-005	HALOPERIDOL	20MG	TABLET / ORAL	AB		2007-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-006	HALOPERIDOL	2MG	TABLET / ORAL	AB		2023-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-001	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		2023-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-002	HALOPERIDOL	1MG	TABLET / ORAL	AB		2023-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-003	HALOPERIDOL	5MG	TABLET / ORAL	AB		2007-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-004	HALOPERIDOL	10MG	TABLET / ORAL	AB		2007-11-29	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077580-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077580-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077580-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077580-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077580-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077580-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077580-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077580-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077580-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077580-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077580-004	AB	1	`b8a1b40f171c…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL	Zydus Lifesciences Limited	509d0eb2-b930-4836-9669-dbebf0ac4076	2024-11-30		Exact identifier ndc (package): 65841-838-77 ndc (package): 65841-838-01 ndc (package): 65841-628-06 ndc (package): 65841-628-01 ndc (package): 65841-627-10 ndc (package): 65841-839-01 ndc (package): 65841-626-01 ndc (package): 65841-627-01 ndc (package): 65841-626-10 ndc (package): 65841-839-77 ndc (package): 65841-837-77 ndc (package): 65841-838-30 ndc (package): 65841-839-10 ndc (package): 65841-838-10 ndc (package): 65841-837-30 ndc (package): 65841-837-01 ndc (package): 65841-839-30 ndc (package): 65841-837-10 ndc (product): 65841-837 ndc (product): 65841-626 ndc (product): 65841-839 ndc (product): 65841-627 ndc (product): 65841-838 ndc (product): 65841-628 ndc11 (package): 65841062806 ndc11 (package): 65841083930 ndc11 (package): 65841062710 ndc11 (package): 65841083801 ndc11 (package): 65841083710 ndc11 (package): 65841083701 ndc11 (package): 65841083830 ndc11 (package): 65841083910 ndc11 (package): 65841062701 ndc11 (package): 65841083730 ndc11 (package): 65841083901 ndc11 (package): 65841083777 ndc11 (package): 65841062610 ndc11 (package): 65841083977 ndc11 (package): 65841083877 ndc11 (package): 65841062601 ndc11 (package): 65841062801 ndc11 (package): 65841083810 spl id: 2ff366f9-878f-4fcb-b2d4-00fb6e31ecbf spl set id: 509d0eb2-b930-4836-9669-dbebf0ac4076

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.