atorvastatin calcium

Product NDC: 50090-7724
Requested package NDC: 50090-7724-0
11-digit product format: 500907724
Labeler code: 50090
Product ID: 50090-7724_f57504eb-f4da-4127-95a9-141333914f0a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atorvastatin calcium
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA206536
Marketing category: ANDA
Marketing start: 2024-06-12
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 80 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 1.

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
A206536-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-11-20
A206536-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-11-20
A206536-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-11-20
A206536-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206536-001	AB
A206536-002	AB
A206536-003	AB
A206536-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A206536-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206536-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206536-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206536-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206536-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206536-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206536-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206536-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206536-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206536-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206536-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206536-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206536-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206536-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206536-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206536-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206536-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206536-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206536-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206536-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206536-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206536-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206536-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206536-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206536-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206536-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206536-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206536-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206536-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206536-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206536-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206536-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206536-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206536-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206536-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206536-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206536-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206536-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206536-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206536-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-11-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206536-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206536-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206536-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206536-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206536-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206536-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206536-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206536-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206536-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206536-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206536-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206536-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206536-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206536-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206536-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206536-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206536-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206536-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206536-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206536-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206536-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206536-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206536-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206536-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206536-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206536-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206536-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206536-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206536-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206536-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206536-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206536-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206536-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206536-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206536-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206536-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206536-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206536-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206536-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206536-004	AB	1	`d06236e962d9…`

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	80 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
259255	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
b8a7c3b3-f87e-4112-9998-578b2613da47	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
50090-7724-0	atorvastatin calcium	30 in 1 BOTTLE	TABLET	30	1
50090-7724-1	atorvastatin calcium	90 in 1 BOTTLE	TABLET	90	1
50090-7724-2	atorvastatin calcium	100 in 1 BOTTLE	TABLET	100	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7724-0	EA - Each	50090-7724	6011f25f-8538-4bd8-88ba-f9f82df8eb75	1	2025-12-16
50090-7724-1	EA - Each	50090-7724	afab63e8-33a6-434c-b61d-fc9e8882d53e	1	2025-12-16
50090-7724-2	EA - Each	50090-7724	3c280a2e-38da-4c94-b997-530f66ec6f1f	1	2025-12-16

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	993c39c2-afe6-4b92-9251-5695f4524a70	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206536 application number: ANDA206536
atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	f6bc1ac6-c96c-4ecf-9935-733587ad6107	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206536 application number: ANDA206536
atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	a102dd8f-25c8-48fa-8244-2d1675f1e1b3	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206536 application number: ANDA206536
atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	af38f580-ce13-436a-a7e3-853c5ac8e540	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206536 application number: ANDA206536
atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	befeea30-acf5-425d-bdea-5c79a9ebfad8	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206536 application number: ANDA206536
atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	54f93ed0-64ef-46bb-aab6-a8dd5dc4c035	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206536 application number: ANDA206536
atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	9271942d-0151-4434-80de-bbccd8868c9c	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206536 application number: ANDA206536
atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	b8a7c3b3-f87e-4112-9998-578b2613da47	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206536 application number: ANDA206536 ndc (package): 50090-7724-0 ndc (product): 50090-7724 ndc11 (package): 50090772400
atorvastatin calcium	ATORVASTATIN CALCIUM	Zydus Pharmaceuticals USA Inc.	55ad4a90-d177-4cce-b7ec-cb75067f6c14	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206536 application number: ANDA206536
atorvastatin calcium	ATORVASTATIN CALCIUM	Zydus Lifesciences Limited	06028adf-fcb5-452c-ba67-ee53bc65c519	2025-05-30		Exact identifier application applno (ANDA): 206536 application number: ANDA206536

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
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	b8a7c3b3-f87e-4112-9998-578b2613da47	1
259255	atorvastatin 80 MG Oral Tablet	SCD	b8a7c3b3-f87e-4112-9998-578b2613da47	1
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	b8a7c3b3-f87e-4112-9998-578b2613da47	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-7724-0	50090772400	30 TABLET in 1 BOTTLE (50090-7724-0)	30 tablet	2025-10-16	No	No	Current