Atorvastatin Calcium

Product NDC: 67046-1458
Requested package NDC: 67046-1458-3
11-digit product format: 670461458
Labeler code: 67046
Product ID: 67046-1458_2d914698-dfd0-014f-e063-6294a90aea25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA214659
Marketing category: ANDA
Marketing start: 2025-02-07
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 10 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
A214659-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14
A214659-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14
A214659-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14
A214659-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214659-001	AB
A214659-002	AB
A214659-003	AB
A214659-004	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 4 · 132 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	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 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	A214659-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214659-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214659-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214659-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214659-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214659-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214659-004	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	10 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
2d916667-7b3e-ea20-e063-6294a90a52da	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
67046-1458-3	Atorvastatin Calcium	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-1458	ATORVASTATIN CALCIUM TABLET [COUPLER LLC]	1	Current NDC, 1 package rows	20250210_2d916667-7b3e-ea20-e063-6294a90a52da.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Dr. Reddy's Laboratories Inc	aaf960d1-8bf9-64c6-1e70-8aa33b0ce549	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	632ddd78-9e76-4230-944d-dff85d945238	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	a519e355-84f0-40d1-b586-e6e8eadb5b0f	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Coupler LLC	2d916667-7b3e-ea20-e063-6294a90a52da	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659 ndc (package): 67046-1458-3 ndc (product): 67046-1458 ndc11 (package): 67046145803
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Coupler LLC	2c658654-87ee-b52a-e063-6294a90a11d6	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	a20bac35-a3d7-4e97-95c2-2502107d61c2	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	9c435528-4c44-44c6-bb10-049a72533c2f	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	a33838d7-4e5e-4079-9d3d-00c2048cf776	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	fa2d8d38-dbd0-43fd-e053-6294a90a4e94	2024-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Dr. Reddy's Laboratories Inc	652f77a0-2145-896d-c760-e99e87507161	2024-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659

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	2d916667-7b3e-ea20-e063-6294a90a52da	1
617312	atorvastatin 10 MG Oral Tablet	SCD	2d916667-7b3e-ea20-e063-6294a90a52da	1
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	2d916667-7b3e-ea20-e063-6294a90a52da	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1458-3	67046145803	30 TABLET in 1 BLISTER PACK (67046-1458-3)	30 tablet	2025-02-07	No	No	Current