Atorvastatin Calcium

Product NDC: 76420-946
Requested package NDC: 76420-946-05
11-digit product format: 764200946
Labeler code: 76420
Product ID: 76420-946_352ed2e2-c7bd-ae21-e063-6394a90ad835
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA209288
Marketing category: ANDA
Marketing start: 2018-12-23
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	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 · 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	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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209288-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209288-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209288-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209288-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-12-21	`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	A209288-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209288-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209288-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209288-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209288-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209288-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209288-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209288-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209288-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209288-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209288-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209288-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209288-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209288-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209288-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209288-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209288-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209288-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209288-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209288-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209288-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209288-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209288-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209288-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209288-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209288-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209288-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209288-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209288-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209288-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209288-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209288-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209288-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209288-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209288-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209288-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209288-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209288-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209288-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209288-004	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: 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
60d51f39-8086-4434-affe-88ab8ca0c7e5	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	SPL version
76420-946-00	Atorvastatin Calcium	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	2
76420-946-05	Atorvastatin Calcium	500 in 1 BOTTLE	TABLET, FILM COATED	500	2
76420-946-12	Atorvastatin Calcium	120 in 1 BOTTLE	TABLET, FILM COATED	120	2
76420-946-20	Atorvastatin Calcium	20 in 1 BOTTLE	TABLET, FILM COATED	20	2
76420-946-23	Atorvastatin Calcium	2000 in 1 BOTTLE	TABLET, FILM COATED	2000	2
76420-946-30	Atorvastatin Calcium	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
76420-946-38	Atorvastatin Calcium	10 in 1 CARTON	TABLET, FILM COATED	10	2
76420-946-38	Atorvastatin Calcium	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	2
76420-946-60	Atorvastatin Calcium	60 in 1 BOTTLE	TABLET, FILM COATED	60	2
76420-946-90	Atorvastatin Calcium	90 in 1 BOTTLE	TABLET, FILM COATED	90	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-946	ATORVASTATIN CALCIUM TABLET, FILM COATED [ASCLEMED USA, INC.]	2	Current NDC, 10 package rows	20250516_60d51f39-8086-4434-affe-88ab8ca0c7e5.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 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 ndc (package): 76420-946-05 ndc (product): 76420-946 ndc11 (package): 76420094605
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	60d51f39-8086-4434-affe-88ab8ca0c7e5	2
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	60d51f39-8086-4434-affe-88ab8ca0c7e5	2
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	60d51f39-8086-4434-affe-88ab8ca0c7e5	2
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	60d51f39-8086-4434-affe-88ab8ca0c7e5	2
617312	atorvastatin 10 MG Oral Tablet	SCD	60d51f39-8086-4434-affe-88ab8ca0c7e5	2
617310	atorvastatin 20 MG Oral Tablet	SCD	60d51f39-8086-4434-affe-88ab8ca0c7e5	2
617311	atorvastatin 40 MG Oral Tablet	SCD	60d51f39-8086-4434-affe-88ab8ca0c7e5	2
259255	atorvastatin 80 MG Oral Tablet	SCD	60d51f39-8086-4434-affe-88ab8ca0c7e5	2
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	60d51f39-8086-4434-affe-88ab8ca0c7e5	2
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	60d51f39-8086-4434-affe-88ab8ca0c7e5	2
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	60d51f39-8086-4434-affe-88ab8ca0c7e5	2
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	60d51f39-8086-4434-affe-88ab8ca0c7e5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
76420-946-05	76420094605	500 TABLET, FILM COATED in 1 BOTTLE (76420-946-05)	2025-04-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atorvastatin Calcium	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-05-15	HUMAN PRESCRIPTION DRUG LABEL	2