RISPERIDONE

Product NDC: 27241-004
11-digit product format: 272410004
Labeler code: 27241
Product ID: 27241-004_8ace73a4-053e-4bd8-ad32-b05807e2f6f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RISPERIDONE
Dosage form: TABLET
Route: ORAL
Labeler: Ajanta Pharma USA Inc.
Application: ANDA201003
Marketing category: ANDA
Marketing start: 2014-03-28
Substance: RISPERIDONE
Active strength: 2 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A201003-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24
A201003-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24
A201003-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24
A201003-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24
A201003-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24
A201003-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201003-001	AB
A201003-002	AB
A201003-003	AB
A201003-004	AB
A201003-005	AB
A201003-006	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 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201003-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201003-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201003-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201003-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201003-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: RISPERIDONE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISPERIDONE	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L6UH7ZF8HC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312828	Internal RxNorm lookup
312829	Internal RxNorm lookup
312830	Internal RxNorm lookup
312831	Internal RxNorm lookup
312832	Internal RxNorm lookup
314211	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
095630bd-a77e-434e-94ee-f13da445d8f2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6	Product name	5	20250303
0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09e	Product name	1	20250128
e457a910-2c3a-4bfd-90b9-0310982c50dd	Product name	1	20241218
42b1a2d5-888a-4386-ab9f-0979e0d7b4aa	Product name	1	20231010
66685e90-862d-4873-a0c5-2be73b803c36	Product name	1	20230921
92d220a1-2a4c-4393-9080-7335ca8223cc	Product name	1	20230823
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
27241-004-06	RISPERIDONE	60 in 1 BOTTLE	TABLET	60		18
27241-004-50	RISPERIDONE	500 in 1 BOTTLE	TABLET	500		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27241-004-06	EA - Each	27241-004	89541236-7edc-4a68-9f3b-8904432d0963	1	2014-06-03
27241-004-50	EA - Each	27241-004	0fc0540e-2abf-422e-8027-dc568c882c12	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET [AJANTA PHARMA LIMITED]	5
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [MSM REPACKAGING]	3
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [MSM REPACKAGING]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET [MSM REPACKAGING]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RISPERIDONE TABLET [MSM REPACKAGING]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET [MSM REPACKAGING]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET [MSM REPACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET [MSM REPACKAGING]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RISPERIDONE TABLET [MSM REPACKAGING]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET [MSM REPACKAGING]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET [MSM REPACKAGING]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RISPERIDONE TABLET [MSM REPACKAGING]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RISPERIDONE TABLET [MSM REPACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET [MSM REPACKAGING]	3
RISPERIDONE	ACTIVE INGREDIENT	L6UH7ZF8HC	RISPERIDONE TABLET [PROFICIENT RX LP]	2
RISPERIDONE	ACTIVE MOIETY	L6UH7ZF8HC	RISPERIDONE TABLET [PROFICIENT RX LP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RISPERIDONE TABLET [PROFICIENT RX LP]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RISPERIDONE TABLET [PROFICIENT RX LP]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RISPERIDONE TABLET [PROFICIENT RX LP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RISPERIDONE TABLET [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RISPERIDONE TABLET [PROFICIENT RX LP]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RISPERIDONE TABLET [PROFICIENT RX LP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RISPERIDONE TABLET [PROFICIENT RX LP]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RISPERIDONE TABLET [PROFICIENT RX LP]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RISPERIDONE TABLET [PROFICIENT RX LP]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RISPERIDONE TABLET [PROFICIENT RX LP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RISPERIDONE TABLET [PROFICIENT RX LP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27241-004	RISPERIDONE TABLET [AJANTA PHARMA USA INC.]	17	Current NDC, Legacy NDC, 2 package rows	20250406_095630bd-a77e-434e-94ee-f13da445d8f2.zip

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RISPERIDONE	RISPERIDONE	Coupler LLC	5643c32b-310e-4888-e063-6394a90ab62f	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ee495f20-c668-4d8f-9684-1029a4f232db	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	03d3b52d-3a7d-4595-84c9-332da6ca9171	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Coupler LLC	52bb35ac-1f7d-bfbe-e063-6294a90aa2b9	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	A-S Medication Solutions	a6767972-2d3f-482b-80bd-ac93e28fdd05	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	bdb08381-dbfc-442e-8d3c-22d3a0f2f6c5	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	2776a647-678d-465c-9db3-4a9459ce779e	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	5d9519af-5a5e-47ce-8a0f-9b9cfac00e19	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ee7d6779-7421-4761-99d2-ccbfde9385a8	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	101b2d4d-4740-4225-94bc-aecc05d82c6b	2026-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	095630bd-a77e-434e-94ee-f13da445d8f2	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003 ndc (product): 27241-004
RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	be388943-fe0c-4c82-ac8e-3df9f77b2891	2025-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
Risperidone	RISPERIDONE	Direct_Rx	0b784f21-fc02-6542-e063-6294a90a285e	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	NuCare Pharmaceuticals,Inc.	79648a52-1364-c25b-e053-2a91aa0a8ea4	2024-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	420cfeef-0061-43b9-9491-dbd6ad866e55	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	aab773b2-a605-4cf8-a301-57e390fe67a6	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	2f83d3e9-04ab-4b24-ad1f-7ed2e784298a	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	e35be034-6275-41fb-bec4-9ae451458701	2024-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	A-S Medication Solutions	523d4f99-1d6f-413f-9d6e-2ca430aaac14	2024-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	bda104ac-1eea-4a1a-836a-24bcc034b90f	2022-11-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L6UH7ZF8HC	RISPERIDONE	106266-06-2	RISPERIDONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312831	risperiDONE 2 MG Oral Tablet	PSN	420cfeef-0061-43b9-9491-dbd6ad866e55	102
312831	risperidone 2 MG Oral Tablet	SCD	420cfeef-0061-43b9-9491-dbd6ad866e55	102
312828	risperiDONE 0.25 MG Oral Tablet	PSN	a6767972-2d3f-482b-80bd-ac93e28fdd05	22
312829	risperiDONE 0.5 MG Oral Tablet	PSN	a6767972-2d3f-482b-80bd-ac93e28fdd05	22
312830	risperiDONE 1 MG Oral Tablet	PSN	a6767972-2d3f-482b-80bd-ac93e28fdd05	22
312831	risperiDONE 2 MG Oral Tablet	PSN	a6767972-2d3f-482b-80bd-ac93e28fdd05	22
312828	risperidone 0.25 MG Oral Tablet	SCD	a6767972-2d3f-482b-80bd-ac93e28fdd05	22
312829	risperidone 0.5 MG Oral Tablet	SCD	a6767972-2d3f-482b-80bd-ac93e28fdd05	22
312830	risperidone 1 MG Oral Tablet	SCD	a6767972-2d3f-482b-80bd-ac93e28fdd05	22
312831	risperidone 2 MG Oral Tablet	SCD	a6767972-2d3f-482b-80bd-ac93e28fdd05	22
312831	risperiDONE 2 MG Oral Tablet	PSN	bdb08381-dbfc-442e-8d3c-22d3a0f2f6c5	19
312831	risperidone 2 MG Oral Tablet	SCD	bdb08381-dbfc-442e-8d3c-22d3a0f2f6c5	19
312828	risperiDONE 0.25 MG Oral Tablet	PSN	095630bd-a77e-434e-94ee-f13da445d8f2	18
312829	risperiDONE 0.5 MG Oral Tablet	PSN	095630bd-a77e-434e-94ee-f13da445d8f2	18
312830	risperiDONE 1 MG Oral Tablet	PSN	095630bd-a77e-434e-94ee-f13da445d8f2	18
312831	risperiDONE 2 MG Oral Tablet	PSN	095630bd-a77e-434e-94ee-f13da445d8f2	18
312832	risperiDONE 3 MG Oral Tablet	PSN	095630bd-a77e-434e-94ee-f13da445d8f2	18
314211	risperiDONE 4 MG Oral Tablet	PSN	095630bd-a77e-434e-94ee-f13da445d8f2	18
312828	risperidone 0.25 MG Oral Tablet	SCD	095630bd-a77e-434e-94ee-f13da445d8f2	18
312829	risperidone 0.5 MG Oral Tablet	SCD	095630bd-a77e-434e-94ee-f13da445d8f2	18
312830	risperidone 1 MG Oral Tablet	SCD	095630bd-a77e-434e-94ee-f13da445d8f2	18
312831	risperidone 2 MG Oral Tablet	SCD	095630bd-a77e-434e-94ee-f13da445d8f2	18
312832	risperidone 3 MG Oral Tablet	SCD	095630bd-a77e-434e-94ee-f13da445d8f2	18
314211	risperidone 4 MG Oral Tablet	SCD	095630bd-a77e-434e-94ee-f13da445d8f2	18
312831	risperiDONE 2 MG Oral Tablet	PSN	5d9519af-5a5e-47ce-8a0f-9b9cfac00e19	15
312831	risperidone 2 MG Oral Tablet	SCD	5d9519af-5a5e-47ce-8a0f-9b9cfac00e19	15
312831	risperiDONE 2 MG Oral Tablet	PSN	2b9cce47-b8b3-4c9b-b26a-3d742a0db8e2	5
312831	risperidone 2 MG Oral Tablet	SCD	2b9cce47-b8b3-4c9b-b26a-3d742a0db8e2	5
312831	risperiDONE 2 MG Oral Tablet	PSN	79648a52-1364-c25b-e053-2a91aa0a8ea4	4
312831	risperidone 2 MG Oral Tablet	SCD	79648a52-1364-c25b-e053-2a91aa0a8ea4	4
312831	risperiDONE 2 MG Oral Tablet	PSN	c2e47d77-6919-44b1-bec0-c410f70a0ebf	3
312831	risperidone 2 MG Oral Tablet	SCD	c2e47d77-6919-44b1-bec0-c410f70a0ebf	3
312831	risperiDONE 2 MG Oral Tablet	PSN	ac152803-d75f-4c3c-bc49-8663b21a3a82	1
312831	risperiDONE 2 MG Oral Tablet	PSN	df611d6c-1919-436a-e053-2a95a90aadc5	1
312831	risperidone 2 MG Oral Tablet	SCD	ac152803-d75f-4c3c-bc49-8663b21a3a82	1
312831	risperidone 2 MG Oral Tablet	SCD	df611d6c-1919-436a-e053-2a95a90aadc5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
27241-004-06	27241000406	60 TABLET in 1 BOTTLE (27241-004-06)	60 tablet	2014-03-28	0000-00-00	No	No	Current
27241-004-50	27241000450	500 TABLET in 1 BOTTLE (27241-004-50)	500 tablet	2014-03-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RISPERIDONE	A-S Medication Solutions	2026-04-02	Human Prescription Drug Label	22
RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	2026-03-23	HUMAN PRESCRIPTION DRUG LABEL	19
RISPERIDONE	REMEDYREPACK INC.	2026-01-26	HUMAN PRESCRIPTION DRUG LABEL	15
RISPERIDONE	Ajanta Pharma USA Inc. \| Ajanta Pharma Limited, Paithan \| Ajanta Pharma Ltd., Dahej	2025-09-16	Human Prescription Drug Label	18
RISPERIDONE	REMEDYREPACK INC.	2025-06-23	HUMAN PRESCRIPTION DRUG LABEL	10
RISPERIDONE	NuCare Pharmaceuticals,Inc. \| NuCare Pharmaceutials,Inc.	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	4
RISPERIDONE	Bryant Ranch Prepack	2024-05-29	HUMAN PRESCRIPTION DRUG LABEL	102
RISPERIDONE	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	5
RISPERIDONE	NuCare Pharmaceuticals,Inc.	2022-05-19	HUMAN PRESCRIPTION DRUG LABEL	1
RISPERIDONE	Preferred Pharmaceuticals Inc.	2021-09-09	HUMAN PRESCRIPTION DRUG LABEL	4
RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	2019-04-29	Human Prescription Drug Label	1
RISPERIDONE	Nucare Pharmaceuticals,Inc.	2017-07-17	HUMAN PRESCRIPTION DRUG LABEL	1
RISPERIDONE	MSM Repackaging	2015-10-14	Human Prescription Drug Label	3