atorvastatin calcium

Product NDC: 68382-251
11-digit product format: 683820251
Labeler code: 68382
Product ID: 68382-251_5f8a8857-027e-4778-91e6-eb4a7f891652
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atorvastatin calcium
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA206536
Marketing category: ANDA
Marketing start: 2018-11-21
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68382-251		D	Discontinued by firm	2026-08-17
excluded package	package	68382-251	68382-251-01	D	Discontinued by firm	2026-08-17
excluded package	package	68382-251	68382-251-05	D	Discontinued by firm	2026-08-17
excluded package	package	68382-251	68382-251-06	D	Discontinued by firm	2026-08-17
excluded package	package	68382-251	68382-251-10	D	Discontinued by firm	2026-08-17
excluded package	package	68382-251	68382-251-16	D	Discontinued by firm	2026-08-17
excluded package	package	68382-251	68382-251-77	D	Discontinued by firm	2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 168 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
2026-08-18 06:07:40	2026-07	A206536-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206536-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206536-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206536-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-11-20	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206536-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206536-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206536-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206536-004	AB	1	`caaa826d4ba7…`
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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-251-10	EA - Each	68382-251	56f70ba7-252d-4a64-98a0-ff46b6bbc9d4	1	2018-12-13
68382-251-16	EA - Each	68382-251	df622e6e-51b5-42af-880e-72be74ca3768	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-251	ATORVASTATIN CALCIUM TABLET [ZYDUS PHARMACEUTICALS USA INC.]	11	Legacy NDC	20241023_f99b0839-28dd-4e77-b920-570af6843052.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 · 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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-251-01	68382025101	100 TABLET in 1 BOTTLE (68382-251-01)	100 tablet	2018-11-21	0000-00-00	No	No	Current
68382-251-05	68382025105	500 TABLET in 1 BOTTLE (68382-251-05)	500 tablet	2018-11-21	0000-00-00	No	No	Current
68382-251-06	68382025106	30 TABLET in 1 BOTTLE (68382-251-06)	30 tablet	2018-11-21	0000-00-00	No	No	Current
68382-251-10	68382025110	1000 TABLET in 1 BOTTLE (68382-251-10)	1000 tablet	2018-11-21	0000-00-00	No	No	Current
68382-251-16	68382025116	90 TABLET in 1 BOTTLE (68382-251-16)	90 tablet	2018-11-21	0000-00-00	No	No	Current
68382-251-77	68382025177	10 BLISTER PACK in 1 CARTON (68382-251-77) > 10 TABLET in 1 BLISTER PACK (68382-251-30)	10 blister pack	2018-11-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
atorvastatin calcium	REMEDYREPACK INC.	2024-12-04	HUMAN PRESCRIPTION DRUG LABEL	4
atorvastatin calcium	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2024-10-21	HUMAN PRESCRIPTION DRUG LABEL	11