Atorvastatin Calcium

Product NDC: 71209-092
Requested package NDC: 71209-092-04
11-digit product format: 712090092
Labeler code: 71209
Product ID: 71209-092_547579c7-a528-413f-b402-00f598775df3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Cadila Pharmaceuticals Limited
Application: ANDA212103
Marketing category: ANDA
Marketing start: 2018-07-06
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 40 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 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	Approval date
A212103-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-10-16
A212103-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-10-16
A212103-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-10-16
A212103-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-10-16

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212103-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212103-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212103-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212103-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212103-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212103-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212103-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212103-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212103-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212103-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212103-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212103-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212103-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212103-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212103-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212103-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212103-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212103-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212103-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212103-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212103-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212103-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212103-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212103-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212103-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212103-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212103-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212103-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212103-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212103-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212103-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212103-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212103-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212103-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212103-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212103-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212103-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212103-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212103-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212103-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-10-16	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212103-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212103-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212103-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212103-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212103-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212103-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212103-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212103-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212103-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212103-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212103-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212103-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212103-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212103-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212103-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212103-004	AB	1	`a72a2bbeb626…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATORVASTATIN CALCIUM TRIHYDRATE	40 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
51730b09-24e8-41c8-9fec-813f8a64b433	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
71209-092-04	Atorvastatin Calcium	90 in 1 BOTTLE	TABLET, COATED	90		8
71209-092-10	Atorvastatin Calcium	500 in 1 BOTTLE	TABLET, COATED	500		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71209-092	ATORVASTATIN CALCIUM TABLET, COATED [CADILA PHARMACEUTICALS LIMITED]	8	Current NDC, 2 package rows	20240607_51730b09-24e8-41c8-9fec-813f8a64b433.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
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Cadila Pharmaceuticals Limited	51730b09-24e8-41c8-9fec-813f8a64b433	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212103 application number: ANDA212103 ndc (package): 71209-092-04 ndc (product): 71209-092 ndc11 (package): 71209009204

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	51730b09-24e8-41c8-9fec-813f8a64b433	8
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	51730b09-24e8-41c8-9fec-813f8a64b433	8
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	51730b09-24e8-41c8-9fec-813f8a64b433	8
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	51730b09-24e8-41c8-9fec-813f8a64b433	8
617312	atorvastatin 10 MG Oral Tablet	SCD	51730b09-24e8-41c8-9fec-813f8a64b433	8
617310	atorvastatin 20 MG Oral Tablet	SCD	51730b09-24e8-41c8-9fec-813f8a64b433	8
617311	atorvastatin 40 MG Oral Tablet	SCD	51730b09-24e8-41c8-9fec-813f8a64b433	8
259255	atorvastatin 80 MG Oral Tablet	SCD	51730b09-24e8-41c8-9fec-813f8a64b433	8
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	51730b09-24e8-41c8-9fec-813f8a64b433	8
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	51730b09-24e8-41c8-9fec-813f8a64b433	8
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	51730b09-24e8-41c8-9fec-813f8a64b433	8
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	51730b09-24e8-41c8-9fec-813f8a64b433	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71209-092-04	71209009204	90 TABLET, COATED in 1 BOTTLE (71209-092-04)	2018-07-06	No	No	Current