ATORVASTATIN CALCIUM

Product NDC: 51655-920
11-digit product format: 516550920
Labeler code: 51655
Product ID: 51655-920_49743995-7fc8-3d7a-e063-6394a90a0755
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATORVASTATIN CALCIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA090548
Marketing category: ANDA
Marketing start: 2014-03-11
Substance: ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
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

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	51655-920-30	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	51655-920-30	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	51655-920-30	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	51655-920-30	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	51655-920-30	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	51655-920-30	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	51655-920-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A090548-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29
A090548-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29
A090548-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29
A090548-004	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
A090548-001	AB
A090548-002	AB
A090548-003	AB
A090548-004	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	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-004	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	A090548-001	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	A090548-002	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	A090548-003	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	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-004	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	A090548-001	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	A090548-002	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	A090548-003	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	A090548-004	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	A090548-001	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	A090548-002	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	A090548-003	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	A090548-004	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	A090548-001	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	A090548-002	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	A090548-003	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	A090548-004	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	A090548-001	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	A090548-002	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	A090548-003	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	A090548-004	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	A090548-001	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	A090548-002	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	A090548-003	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	A090548-004	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	A090548-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090548-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090548-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090548-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090548-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090548-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090548-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090548-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090548-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090548-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-004	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 PROPYLENE GLYCOL SOLVATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YRZ789OWMI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
617310	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
0e10adb3-8d3a-412f-ae56-d9b9bed4641f	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
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
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
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-920-30	2023-10-31	C162847	48780-1	9d75b9d0-d315-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
51655-920-30	2020-01-31	C162847	48780-1	9d75b9d0-d315-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51655-920-26	ATORVASTATIN CALCIUM	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	4
51655-920-30	ATORVASTATIN CALCIUM	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
51655-920-83	ATORVASTATIN CALCIUM	180 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	180	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
ATORVASTATIN CALCIUM	ACTIVE INGREDIENT	48A5M73Z4Q	ATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]	1
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	ATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-920	ATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	3	Current NDC, Legacy NDC, 3 package rows	20240814_0e10adb3-8d3a-412f-ae56-d9b9bed4641f.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 2 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	30b9250c-00f6-cc7b-e063-6294a90a5a0e	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	694a6a7f-9d46-46b0-9329-ad8c2bd5e403	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	25015637-c825-487c-ac33-c5ac46a4732f	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	40e6b63f-0a20-404a-8915-2f698877a96b	2024-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	47709fe3-88d3-4d2e-b9db-a06dc1c2c7d4	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	6c1e9bf3-ef52-4053-933d-5a5f7405e642	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	46df076d-4e98-6faa-e054-00144ff8d46c	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	e1935ab1-051b-7081-e053-2995a90a0901	2024-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	7afe2137-b8b6-4506-818a-e5fadb2aee51	2023-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	4ed5fd35-8212-4eb4-bf44-aeca788e4e4c	2023-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	1b8c55ef-160d-42df-95d1-c008f1182e3e	2023-09-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	107d7aed-582d-4296-99e9-ec63c41a594c	2023-08-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	77675dc3-868d-42a3-a179-80372a23e0c8	2023-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	0ab0bcac-10a3-4178-9674-3730683a4183	2023-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	cbbdd932-a43b-4e88-af6d-cfe994c941b3	2023-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Proficient Rx LP	44f0df8b-6069-4941-87e9-2c57c8dfddfa	2022-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Proficient Rx LP	957feff4-5005-4eea-bbe2-7232be65b0eb	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	2b7fbe2a-1f7a-4944-b589-87ca05af7481	2022-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	c0b4f1a2-0082-4150-8f2b-e7440252b675	2019-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YRZ789OWMI	ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE	1040350-07-9	ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	0e10adb3-8d3a-412f-ae56-d9b9bed4641f	4
617310	atorvastatin 20 MG Oral Tablet	SCD	0e10adb3-8d3a-412f-ae56-d9b9bed4641f	4
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	0e10adb3-8d3a-412f-ae56-d9b9bed4641f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51655-920-26	51655092026	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-920-26)	2022-08-17	No	No	Current
51655-920-30	51655092030	30 TABLET, FILM COATED in 1 BOTTLE (51655-920-30)	2014-03-11	No	No	Current
51655-920-83	51655092083	180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-920-83)	2023-01-05	No	No	Current