Atorvastatin Calcium

Product NDC: 81033-513
11-digit product format: 810330513
Labeler code: 81033
Product ID: 81033-513_56826bb5-ae71-af65-e063-6294a90abf74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Kesin Pharma Corporation
Application: ANDA209288
Marketing category: ANDA
Marketing start: 2018-12-23
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 44.

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
A209288-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-12-21
A209288-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-12-21
A209288-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-12-21
A209288-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209288-001	AB
A209288-002	AB
A209288-003	AB
A209288-004	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 · 176 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
2026-10-15 13:18:30	2026-09	A209288-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209288-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209288-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209288-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-12-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209288-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209288-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209288-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209288-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209288-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209288-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209288-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209288-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209288-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209288-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209288-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209288-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209288-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209288-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209288-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209288-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209288-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209288-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209288-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209288-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209288-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209288-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209288-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209288-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209288-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209288-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209288-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209288-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209288-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209288-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209288-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209288-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209288-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209288-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209288-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209288-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-12-21	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A209288-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209288-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209288-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209288-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209288-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209288-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209288-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209288-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209288-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209288-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209288-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209288-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209288-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209288-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209288-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209288-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209288-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209288-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209288-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209288-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209288-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209288-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209288-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209288-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209288-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209288-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209288-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209288-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209288-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209288-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209288-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209288-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209288-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209288-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209288-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209288-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209288-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209288-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209288-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209288-004	AB	1	`ea99ee380514…`

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	20 mg/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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	57f9b462-f08e-483c-9b64-b7e4c8d46927	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	09cb8375-075c-47e8-a4eb-8ac667ed849e	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	c9f55cb6-a41b-dd27-e053-2a95a90aaeb7	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	f3084cae-db82-4e6f-e053-2995a90aa36a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	da6b77a5-2093-b7f7-e053-2995a90ab10d	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	QPharma, Inc.	bd216f5d-f319-7d8d-e053-2a95a90aa9ce	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	QPharma, Inc.	c0e2a5d0-1aa3-e131-e053-2a95a90a9870	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Asclemed USA, Inc.	60d51f39-8086-4434-affe-88ab8ca0c7e5	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Ascend Laboratories, LLC	67e60880-091a-4df7-8696-6e6c42a490e2	2025-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	2035c49b-f319-4dce-bf1c-c2f64e786fb7	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	95729689-8055-45ae-e053-2995a90a919f	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	8ee8b455-625c-ead6-e053-2a95a90aed29	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	862f9f27-c645-2d2e-e053-2991aa0a96b9	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	862f58d1-476c-2c90-e053-2991aa0ab821	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	1cc2dd41-a465-45b6-a80a-67c41af29cf8	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	2ad89657-cc95-44a0-af6a-ee756526aa10	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	103cc381-3266-409d-bdc2-1de620bae355	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	e52b4b11-9618-4787-ae67-44e4a3166dfb	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	0ec97c59-9d17-45f8-93f9-2c1f0361cb75	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	e6d068ed-f9d2-4fd1-9755-b76bea89725e	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209288 application number: ANDA209288

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
81033-513-01	81033051301	10 BLISTER PACK in 1 CARTON (81033-513-01) / 100 TABLET, FILM COATED in 1 BLISTER PACK (81033-513-20)	10 blister pack	2026-08-01	No	No	Current