Atorvastatin Calcium

Product NDC: 55154-0284
11-digit product format: 551540284
Labeler code: 55154
Product ID: 55154-0284_fbd1c5da-67fb-4412-acb5-4d4c74a43654
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atorvastatin calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA091226
Marketing category: ANDA
Marketing start: 2026-07-24
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 80 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 43.

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
A091226-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29
A091226-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29
A091226-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29
A091226-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091226-001	AB
A091226-002	AB
A091226-003	AB
A091226-004	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 5 · 172 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
2026-09-14 22:38:34	2026-08	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091226-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091226-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091226-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091226-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091226-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091226-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091226-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091226-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091226-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091226-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091226-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091226-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091226-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091226-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091226-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091226-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	80 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
259255	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
fbd1c5da-67fb-4412-acb5-4d4c74a43654	Available on FDA.report

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	aee307d6-b3fa-424f-8656-1f30ff413e95	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091226 application number: ANDA091226
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	fbd1c5da-67fb-4412-acb5-4d4c74a43654	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091226 application number: ANDA091226 ndc (product): 55154-0284
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Mylan Pharmaceuticals Inc.	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091226 application number: ANDA091226
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Safecor Health, LLC	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091226 application number: ANDA091226
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Mylan Institutional Inc.	7c1083b9-7a20-475d-ba12-4f5d0b53e601	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091226 application number: ANDA091226

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55154-0284-6	55154028406	6 BLISTER PACK in 1 BAG (55154-0284-6) / 1 TABLET, FILM COATED in 1 BLISTER PACK	6 blister pack	2026-07-24	No	No	Current