Atorvastatin Calcium

Product NDC: 68071-2824
Requested package NDC: 68071-2824-9
11-digit product format: 680712824
Labeler code: 68071
Product ID: 68071-2824_49dcce98-eb2c-0b98-e063-6394a90abbee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA076477
Marketing category: ANDA
Marketing start: 2011-12-01
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: 2027-12-31
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	Approval date
A076477-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2011-11-30
A076477-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2011-11-30
A076477-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2011-11-30
A076477-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2011-11-30

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 5 · 164 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	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076477-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076477-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076477-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076477-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076477-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076477-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076477-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076477-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076477-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076477-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076477-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076477-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076477-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076477-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076477-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076477-004	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Atorvastatin Calcium
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
617310	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
49dcc58a-9f23-045d-e063-6394a90abda6	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
68071-2824-9	Atorvastatin Calcium	90 in 1 BOTTLE	TABLET, FILM COATED	90		1

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	2e583569-499d-4f20-87ca-84e7d9868d22	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Sun Pharmaceutical Industries Inc.	595ab888-6b55-4642-a32f-e8521821ed81	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	49dcc58a-9f23-045d-e063-6394a90abda6	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477 ndc (package): 68071-2824-9 ndc (product): 68071-2824 ndc11 (package): 68071282409
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	DIRECT RX	c3b70f79-45a3-0869-e053-2a95a90a3cdb	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	f7af3b3a-b73e-41ee-80e3-2be036672bb7	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	b1a840cf-47aa-b931-e053-2a95a90a1047	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	bbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	d77e155c-403d-449e-bafd-11c9bd4974dd	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477

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
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	49dcc58a-9f23-045d-e063-6394a90abda6	1
617310	atorvastatin 20 MG Oral Tablet	SCD	49dcc58a-9f23-045d-e063-6394a90abda6	1
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	49dcc58a-9f23-045d-e063-6394a90abda6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-2824-9	68071282409	90 TABLET, FILM COATED in 1 BOTTLE (68071-2824-9)	2026-02-02	No	No	Current