ATORVALIQ

Product NDC: 46287-030
11-digit product format: 462870030
Labeler code: 46287
Product ID: 46287-030_fb92775a-6d6d-4d62-ab23-045f16ec5895
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATORVALIQ
Dosage form: SUSPENSION
Route: ORAL
Labeler: CMP Pharma, Inc.
Application: NDA213260
Marketing category: NDA
Marketing start: 2023-03-01
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 20 mg/5mL
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213260-001	ATORVALIQ	ATORVASTATIN CALCIUM	20MG/5ML	SUSPENSION / ORAL		RLD, RS	2023-02-01

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213260-001	11369567	2037-06-07		Drug product	2023-02-07
N213260-001	11654106	2037-06-07	U-3612	Drug product	2023-06-01
N213260-001	11654106	2037-06-07	U-3613	Drug product	2023-06-01
N213260-001	11925704	2037-06-07	U-3853	Drug product	2024-03-25
N213260-001	12168069	2037-06-07		Drug product	2024-12-19
N213260-001	12370136	2037-06-07		Drug product	2025-07-30
N213260-001	12599553	2037-06-07		Drug product	2026-05-06

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213260-001	ATORVALIQ	20MG/5ML	SUSPENSION / ORAL	RLD, RS	2023-02-01	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 94 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213260-001	11369567	2037-06-07		Drug product	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213260-001	11654106	2037-06-07	U-3612	Drug product	2023-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213260-001	11654106	2037-06-07	U-3613	Drug product	2023-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213260-001	11925704	2037-06-07	U-3853	Drug product	2024-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213260-001	12168069	2037-06-07		Drug product	2024-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213260-001	12370136	2037-06-07		Drug product	2025-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213260-001	11369567	2037-06-07		Drug product	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213260-001	11654106	2037-06-07	U-3612	Drug product	2023-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213260-001	11654106	2037-06-07	U-3613	Drug product	2023-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213260-001	11925704	2037-06-07	U-3853	Drug product	2024-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213260-001	12168069	2037-06-07		Drug product	2024-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213260-001	12370136	2037-06-07		Drug product	2025-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213260-001	11369567	2037-06-07		Drug product	2023-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213260-001	11654106	2037-06-07	U-3612	Drug product	2023-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213260-001	11654106	2037-06-07	U-3613	Drug product	2023-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213260-001	11925704	2037-06-07	U-3853	Drug product	2024-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213260-001	12168069	2037-06-07		Drug product	2024-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213260-001	12370136	2037-06-07		Drug product	2025-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213260-001	11369567	2037-06-07		Drug product	2023-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213260-001	11654106	2037-06-07	U-3612	Drug product	2023-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213260-001	11654106	2037-06-07	U-3613	Drug product	2023-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213260-001	11925704	2037-06-07	U-3853	Drug product	2024-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213260-001	12168069	2037-06-07		Drug product	2024-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213260-001	11369567	2037-06-07		Drug product	2023-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213260-001	11654106	2037-06-07	U-3612	Drug product	2023-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213260-001	11654106	2037-06-07	U-3613	Drug product	2023-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213260-001	11925704	2037-06-07	U-3853	Drug product	2024-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213260-001	12168069	2037-06-07		Drug product	2024-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213260-001	11369567	2037-06-07		Drug product	2023-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213260-001	11654106	2037-06-07	U-3612	Drug product	2023-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213260-001	11654106	2037-06-07	U-3613	Drug product	2023-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213260-001	11925704	2037-06-07	U-3853	Drug product	2024-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213260-001	12168069	2037-06-07		Drug product	2024-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213260-001	11369567	2037-06-07		Drug product	2023-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213260-001	11654106	2037-06-07	U-3612	Drug product	2023-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213260-001	11654106	2037-06-07	U-3613	Drug product	2023-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213260-001	11925704	2037-06-07	U-3853	Drug product	2024-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213260-001	11369567	2037-06-07		Drug product	2023-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213260-001	11654106	2037-06-07	U-3612	Drug product	2023-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213260-001	11654106	2037-06-07	U-3613	Drug product	2023-06-01	`5bbf6a4d5a75…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATORVASTATIN CALCIUM TRIHYDRATE	20 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
48A5M73Z4Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2630760	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
41fca2d8-7f3f-45b9-8974-81b89accc211	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
d25cba4b-d79e-4890-8837-1382f7d09489	Product name	1	20231002
91774e91-b249-45e3-8ff8-4b5db2927a69	Product name	1	20230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1c	Product name	1	20220302
34152997-af0b-acf4-dcaf-37211afe8ca4	Product name	9	20210312
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46287-030-01	ATORVALIQ	150 mL in 1 BOTTLE	Suspension	150		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46287-030-01	ML - Milliliter	46287-030	9a27be70-35b8-477b-88db-768e79c562c4	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46287-030	ATORVALIQ SUSPENSION [CMP PHARMA, INC.]	3	Current NDC, 1 package rows	20240823_41fca2d8-7f3f-45b9-8974-81b89accc211.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATORVALIQ	ATORVALIQ	CMP Pharma, Inc.	41fca2d8-7f3f-45b9-8974-81b89accc211	2024-04-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213260 application number: NDA213260 ndc (product): 46287-030

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
48A5M73Z4Q	ATORVASTATIN CALCIUM TRIHYDRATE	344423-98-9	ATORVASTATIN CALCIUM TRIHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2630760	atorvastatin calcium 20 MG in 5 mL Oral Suspension	PSN	41fca2d8-7f3f-45b9-8974-81b89accc211	3
2630760	atorvastatin 4 MG/ML Oral Suspension	SCD	41fca2d8-7f3f-45b9-8974-81b89accc211	3
2630760	atorvastatin (as atorvastatin calcium) 20 MG per 5 ML Oral Suspension	SY	41fca2d8-7f3f-45b9-8974-81b89accc211	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
46287-030-01	46287003001	150 mL in 1 BOTTLE (46287-030-01)	150 ml	2023-03-01	No	No	Current