Atorvastatin Calcium

Product NDC: 71335-9723
11-digit product format: 713359723
Labeler code: 71335
Product ID: 71335-9723_6b6c1e31-f207-400f-9599-a2f96c5bb3c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA214659
Marketing category: ANDA
Marketing start: 2022-08-29
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-9723-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-9723-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-9723-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-9723-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-9723-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-9723-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-9723-7	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71335-9723-5	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71335-9723-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71335-9723-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71335-9723-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71335-9723-6	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71335-9723-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71335-9723-7	`367a005e9d99…`	`383a685ebd0f…`

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
A214659-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14
A214659-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14
A214659-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14
A214659-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214659-001	AB
A214659-002	AB
A214659-003	AB
A214659-004	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 4 · 140 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	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-07-14	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 116 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	A214659-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214659-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214659-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214659-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214659-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214659-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214659-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214659-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214659-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214659-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214659-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214659-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214659-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214659-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214659-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214659-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214659-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214659-004	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
617311	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
a20bac35-a3d7-4e97-95c2-2502107d61c2	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
71335-9723-1	Atorvastatin Calcium	30 in 1 BOTTLE	TABLET	30	103
71335-9723-2	Atorvastatin Calcium	100 in 1 BOTTLE	TABLET	100	103
71335-9723-3	Atorvastatin Calcium	90 in 1 BOTTLE	TABLET	90	103
71335-9723-4	Atorvastatin Calcium	60 in 1 BOTTLE	TABLET	60	103
71335-9723-5	Atorvastatin Calcium	180 in 1 BOTTLE	TABLET	180	103
71335-9723-6	Atorvastatin Calcium	10 in 1 BOTTLE	TABLET	10	103
71335-9723-7	Atorvastatin Calcium	7 in 1 BOTTLE	TABLET	7	103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-9723	ATORVASTATIN CALCIUM TABLET [BRYANT RANCH PREPACK]	103	Current NDC, 7 package rows	20241115_a20bac35-a3d7-4e97-95c2-2502107d61c2.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Dr. Reddy's Laboratories Inc	aaf960d1-8bf9-64c6-1e70-8aa33b0ce549	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Coupler LLC	2d916667-7b3e-ea20-e063-6294a90a52da	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Coupler LLC	2c658654-87ee-b52a-e063-6294a90a11d6	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	a20bac35-a3d7-4e97-95c2-2502107d61c2	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659 ndc (product): 71335-9723
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	9c435528-4c44-44c6-bb10-049a72533c2f	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	a33838d7-4e5e-4079-9d3d-00c2048cf776	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	fa2d8d38-dbd0-43fd-e053-6294a90a4e94	2024-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Dr. Reddy's Laboratories Inc	652f77a0-2145-896d-c760-e99e87507161	2024-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214659 application number: ANDA214659

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
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	a20bac35-a3d7-4e97-95c2-2502107d61c2	103
617311	atorvastatin 40 MG Oral Tablet	SCD	a20bac35-a3d7-4e97-95c2-2502107d61c2	103
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	a20bac35-a3d7-4e97-95c2-2502107d61c2	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-9723-1	71335972301	30 TABLET in 1 BOTTLE (71335-9723-1)	30 tablet	2023-07-06	No	No	Current
71335-9723-2	71335972302	100 TABLET in 1 BOTTLE (71335-9723-2)	100 tablet	2024-04-22	No	No	Current
71335-9723-3	71335972303	90 TABLET in 1 BOTTLE (71335-9723-3)	90 tablet	2023-06-07	No	No	Current
71335-9723-4	71335972304	60 TABLET in 1 BOTTLE (71335-9723-4)	60 tablet	2024-07-16	No	No	Current
71335-9723-5	71335972305	180 TABLET in 1 BOTTLE (71335-9723-5)	180 tablet	2024-04-22	No	No	Current
71335-9723-6	71335972306	10 TABLET in 1 BOTTLE (71335-9723-6)	10 tablet	2024-04-22	No	No	Current
71335-9723-7	71335972307	7 TABLET in 1 BOTTLE (71335-9723-7)	7 tablet	2024-07-16	No	No	Current