Atorvastatin Calcium

Product NDC: 70934-070
Requested package NDC: 70934-070-30
11-digit product format: 709340070
Labeler code: 70934
Product ID: 70934-070_b7df2c42-039f-9a03-e053-2a95a90a49dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA091624
Marketing category: ANDA
Marketing start: 2018-01-25
Marketing end: 0000-00-00
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 10 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70934-070	70934-070-30	I	Inactivated by FDA		2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A091624-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05
A091624-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05
A091624-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05
A091624-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091624-001	AB
A091624-002	AB
A091624-003	AB
A091624-004	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	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`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	A091624-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091624-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091624-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091624-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091624-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091624-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091624-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091624-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091624-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091624-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091624-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091624-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091624-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091624-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091624-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091624-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70934-070-30	2023-01-30	C162847	48780-1	f386c64a-22b6-0266-e053-dadaa90a7c1a	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	Strength	SPL version
70934-070-30	Atorvastatin Calcium	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70934-070-30	EA - Each	70934-070	a7eb4bbb-5e94-4a62-9766-769e91fe8a55	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70934-070	ATORVASTATIN CALCIUM TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]	3	Legacy NDC, 1 package rows	20210102_6440edee-7121-78f2-e053-2991aa0a604e.zip

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	6440edee-7121-78f2-e053-2991aa0a604e	3
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	6440edee-7121-78f2-e053-2991aa0a604e	3
617312	atorvastatin 10 MG Oral Tablet	SCD	6440edee-7121-78f2-e053-2991aa0a604e	3
617310	atorvastatin 20 MG Oral Tablet	SCD	6440edee-7121-78f2-e053-2991aa0a604e	3
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	6440edee-7121-78f2-e053-2991aa0a604e	3
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	6440edee-7121-78f2-e053-2991aa0a604e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-070-30	70934007030	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-070-30)	2018-01-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atorvastatin Calcium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3