ATORVASTATIN CALCIUM

Product NDC: 31722-425
11-digit product format: 317220425
Labeler code: 31722
Product ID: 31722-425_3afbe0e5-4ded-60ee-e063-6294a90a13a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATORVASTATIN CALCIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA214344
Marketing category: ANDA
Marketing start: 2023-09-12
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 20 mg/1
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214344-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2023-09-12
A214344-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2023-09-12
A214344-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2023-09-12
A214344-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2023-09-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A214344-001	AB
A214344-002	AB
A214344-003	AB
A214344-004	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 2 · 80 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	A214344-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2023-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214344-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2023-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214344-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2023-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214344-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2023-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214344-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2023-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214344-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2023-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214344-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2023-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214344-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2023-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214344-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2023-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214344-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2023-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214344-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2023-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214344-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2023-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214344-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2023-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214344-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2023-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214344-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2023-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214344-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2023-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214344-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2023-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214344-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2023-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214344-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2023-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214344-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2023-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214344-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2023-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214344-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2023-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214344-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2023-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214344-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2023-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214344-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2023-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214344-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2023-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214344-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2023-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214344-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2023-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214344-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2023-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214344-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2023-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214344-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2023-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214344-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2023-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214344-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2023-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214344-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2023-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214344-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2023-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214344-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2023-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214344-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2023-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214344-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2023-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214344-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2023-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214344-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2023-09-12	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A214344-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214344-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214344-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214344-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214344-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214344-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214344-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214344-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214344-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214344-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214344-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214344-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214344-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214344-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214344-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214344-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214344-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214344-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214344-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214344-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214344-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214344-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214344-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214344-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214344-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214344-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214344-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214344-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214344-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214344-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214344-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214344-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214344-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214344-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214344-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214344-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214344-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214344-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214344-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214344-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATORVASTATIN CALCIUM TRIHYDRATE	20 mg/1

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
259255	Internal RxNorm lookup
617310	Internal RxNorm lookup
617311	Internal RxNorm lookup
617312	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
25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	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	SPL version
31722-425-05	ATORVASTATIN CALCIUM	500 in 1 BOTTLE	TABLET, FILM COATED	500	5
31722-425-10	ATORVASTATIN CALCIUM	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	5
31722-425-90	ATORVASTATIN CALCIUM	90 in 1 BOTTLE	TABLET, FILM COATED	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-425-05	EA - Each	31722-425	5402b20a-4119-4bad-8907-e0291162ba4c	1	2024-03-12
31722-425-10	EA - Each	31722-425	3768224f-1482-47ad-a154-b20f009f20e6	1	2024-03-12
31722-425-90	EA - Each	31722-425	64d8da1a-8753-4866-88ad-0bbbe377a360	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-425	ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	4	Current NDC, 3 package rows	20240929_25c8f92f-9cb6-482b-82e1-16ad7c94e7b3.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 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	St. Mary's Medical Park Pharmacy	2f76cd3b-fbfa-a193-e063-6294a90a1b32	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	St. Mary's Medical Park Pharmacy	1ea6235f-633c-af0b-e063-6294a90aad6d	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	200c1994-9327-e02c-e063-6394a90a593d	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	c8b186e4-28c2-4bf9-8964-5a5f3ca3a2da	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	db32eb1a-d282-47df-afa2-f250e3c67e71	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	f15094eb-3161-441e-b8ea-c33db2af6b50	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Preferred Pharmaceuticals, Inc.	5327cf20-81e0-4b46-8c86-88c0ddd19c5f	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Redpharm Drug	301ef8f1-6b5f-234b-e063-6294a90ad2d3	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	330d488b-794d-416b-8ec7-073946e3fdf5	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	a4185ea4-8fc1-4af5-99b1-6e49f0c46463	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	06abf2dc-5ebd-4d42-b43c-7deeb93925dd	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	811e6733-fa82-4b41-b426-fe24aa70e601	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	1e9151aa-053f-a17d-e063-6294a90afea5	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Quallent Pharmaceuticals Health LLC	5b94b6f4-6f64-4551-abcb-8e845fb13813	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Camber Pharmaceuticals, Inc.	25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344 ndc (product): 31722-425
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	395dbb88-5889-c91c-e063-6394a90a8daf	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	258d8737-0b80-7d80-e063-6394a90adc8e	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	ac98cfd7-fd4c-4fe1-91f3-50a0e232364f	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	2f84fd12-3e13-47b0-a628-d22a7c4ac3c0	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	766690b2-9784-4496-9cf3-d5584ae605de	2025-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214344 application number: ANDA214344

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
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	5
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	5
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	5
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	5
617312	atorvastatin 10 MG Oral Tablet	SCD	25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	5
617310	atorvastatin 20 MG Oral Tablet	SCD	25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	5
617311	atorvastatin 40 MG Oral Tablet	SCD	25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	5
259255	atorvastatin 80 MG Oral Tablet	SCD	25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	5
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	5
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	5
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	5
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	5
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	258d8737-0b80-7d80-e063-6394a90adc8e	4
617310	atorvastatin 20 MG Oral Tablet	SCD	258d8737-0b80-7d80-e063-6394a90adc8e	4
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	258d8737-0b80-7d80-e063-6394a90adc8e	4
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	c8b186e4-28c2-4bf9-8964-5a5f3ca3a2da	3
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	db32eb1a-d282-47df-afa2-f250e3c67e71	3
617310	atorvastatin 20 MG Oral Tablet	SCD	db32eb1a-d282-47df-afa2-f250e3c67e71	3
617310	atorvastatin 20 MG Oral Tablet	SCD	c8b186e4-28c2-4bf9-8964-5a5f3ca3a2da	3
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	db32eb1a-d282-47df-afa2-f250e3c67e71	3
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	c8b186e4-28c2-4bf9-8964-5a5f3ca3a2da	3
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	5327cf20-81e0-4b46-8c86-88c0ddd19c5f	2
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	1e9151aa-053f-a17d-e063-6294a90afea5	2
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	5327cf20-81e0-4b46-8c86-88c0ddd19c5f	2
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	4b2d0de1-50f0-4356-aa79-88696be8ac3d	2
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	23ac06e0-556c-c640-e063-6394a90a931d	2
617312	atorvastatin 10 MG Oral Tablet	SCD	5327cf20-81e0-4b46-8c86-88c0ddd19c5f	2
617310	atorvastatin 20 MG Oral Tablet	SCD	4b2d0de1-50f0-4356-aa79-88696be8ac3d	2
617310	atorvastatin 20 MG Oral Tablet	SCD	1e9151aa-053f-a17d-e063-6294a90afea5	2
617310	atorvastatin 20 MG Oral Tablet	SCD	23ac06e0-556c-c640-e063-6394a90a931d	2
617310	atorvastatin 20 MG Oral Tablet	SCD	5327cf20-81e0-4b46-8c86-88c0ddd19c5f	2
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	5327cf20-81e0-4b46-8c86-88c0ddd19c5f	2
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	1e9151aa-053f-a17d-e063-6294a90afea5	2
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	4b2d0de1-50f0-4356-aa79-88696be8ac3d	2
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	5327cf20-81e0-4b46-8c86-88c0ddd19c5f	2
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	23ac06e0-556c-c640-e063-6394a90a931d	2
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	2f2152b6-790c-aa4a-e063-6294a90a3b18	1
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	2f76cd3b-fbfa-a193-e063-6294a90a1b32	1
617310	atorvastatin 20 MG Oral Tablet	SCD	2f2152b6-790c-aa4a-e063-6294a90a3b18	1
617310	atorvastatin 20 MG Oral Tablet	SCD	2f76cd3b-fbfa-a193-e063-6294a90a1b32	1
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	2f2152b6-790c-aa4a-e063-6294a90a3b18	1
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	2f76cd3b-fbfa-a193-e063-6294a90a1b32	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
31722-425-05	31722042505	500 TABLET, FILM COATED in 1 BOTTLE (31722-425-05)	2023-09-12	No	No	Current
31722-425-10	31722042510	1000 TABLET, FILM COATED in 1 BOTTLE (31722-425-10)	2023-09-12	No	No	Current
31722-425-90	31722042590	90 TABLET, FILM COATED in 1 BOTTLE (31722-425-90)	2023-09-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATORVASTATIN CALCIUM	St. Mary's Medical Park Pharmacy	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	2
ATORVASTATIN CALCIUM	A-S Medication Solutions	2026-02-17	HUMAN PRESCRIPTION DRUG LABEL	3
ATORVASTATIN CALCIUM	A-S Medication Solutions	2026-02-17	HUMAN PRESCRIPTION DRUG LABEL	3
ATORVASTATIN CALCIUM	Preferred Pharmaceuticals, Inc.	2026-01-16	HUMAN PRESCRIPTION DRUG LABEL	2
ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	2025-09-22	HUMAN PRESCRIPTION DRUG LABEL	2
ATORVASTATIN CALCIUM	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit V \| Annora Pharma Private Limited	2025-07-28	HUMAN PRESCRIPTION DRUG LABEL	5
ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	2025-06-10	HUMAN PRESCRIPTION DRUG LABEL	4
ATORVASTATIN CALCIUM	Coupler LLC	2025-02-27	HUMAN PRESCRIPTION DRUG LABEL	1
Atorvastatin Calcium	Direct_Rx	2025-01-14	HUMAN PRESCRIPTION DRUG LABEL	2
ATORVASTATIN CALCIUM	Proficient Rx LP	2024-11-01	HUMAN PRESCRIPTION DRUG LABEL	2
ATORVASTATIN CALCIUM	REMEDYREPACK INC.	2024-06-17	HUMAN PRESCRIPTION DRUG LABEL	1