Atorvastatin Calcium

Product NDC: 42708-004
Requested package NDC: 42708-004-30
11-digit product format: 427080004
Labeler code: 42708
Product ID: 42708-004_45b41a94-e930-c847-e063-6394a90ad348
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: QPharma, Inc.
Application: ANDA205300
Marketing category: ANDA
Marketing start: 2017-05-04
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 20 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 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
A205300-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-27
A205300-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-27
A205300-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-27
A205300-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2017-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205300-001	AB
A205300-002	AB
A205300-003	AB
A205300-004	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	A205300-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205300-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205300-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205300-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2017-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205300-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205300-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205300-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205300-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2017-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205300-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205300-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205300-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205300-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2017-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205300-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205300-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205300-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205300-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2017-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205300-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205300-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205300-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205300-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2017-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205300-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205300-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205300-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205300-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2017-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205300-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205300-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205300-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205300-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2017-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205300-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205300-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205300-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205300-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2017-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205300-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205300-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205300-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205300-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2017-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205300-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205300-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205300-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205300-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2017-03-27	`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	A205300-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205300-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205300-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205300-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205300-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205300-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205300-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205300-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205300-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205300-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205300-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205300-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205300-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205300-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205300-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205300-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205300-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205300-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205300-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205300-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205300-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205300-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205300-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205300-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205300-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205300-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205300-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205300-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205300-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205300-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205300-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205300-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205300-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205300-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205300-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205300-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205300-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205300-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205300-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205300-004	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	20 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
617310	Internal RxNorm lookup
617311	Internal RxNorm lookup
617312	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
3e59aa97-5480-41e0-86b0-047e648b976d	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42708-004-30	2021-03-12	C162847	48780-1	ba0f9c33-5e9e-a910-e053-dadaa90a0b85	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
42708-004-30	2021-01-29	C162847	48780-1	ba0f9c33-5e9e-a910-e053-dadaa90a0b85	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
42708-004-30	Atorvastatin Calcium	30 in 1 BOTTLE	TABLET, FILM COATED	30		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42708-004	ATORVASTATIN CALCIUM TABLET, FILM COATED [QPHARMA, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20241128_3e59aa97-5480-41e0-86b0-047e648b976d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	QPharma, Inc.	3e59aa97-5480-41e0-86b0-047e648b976d	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205300 application number: ANDA205300 ndc (package): 42708-004-30 ndc (product): 42708-004 ndc11 (package): 42708000430
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Teva Pharmaceuticals USA, Inc.	86841382-4229-4e03-958e-3ac22639efd4	2024-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205300 application number: ANDA205300
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	bd56a76b-5570-46a7-9399-fc110d913bf9	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205300 application number: ANDA205300

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	3e59aa97-5480-41e0-86b0-047e648b976d	8
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	3e59aa97-5480-41e0-86b0-047e648b976d	8
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	3e59aa97-5480-41e0-86b0-047e648b976d	8
617312	atorvastatin 10 MG Oral Tablet	SCD	3e59aa97-5480-41e0-86b0-047e648b976d	8
617310	atorvastatin 20 MG Oral Tablet	SCD	3e59aa97-5480-41e0-86b0-047e648b976d	8
617311	atorvastatin 40 MG Oral Tablet	SCD	3e59aa97-5480-41e0-86b0-047e648b976d	8
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	3e59aa97-5480-41e0-86b0-047e648b976d	8
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	3e59aa97-5480-41e0-86b0-047e648b976d	8
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	3e59aa97-5480-41e0-86b0-047e648b976d	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42708-004-30	42708000430	30 TABLET, FILM COATED in 1 BOTTLE (42708-004-30)	2018-05-31	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atorvastatin Calcium	QPharma, Inc. \| Teva Pharmaceuticals USA, Inc. \| Northwind Health Company, LLC	2025-12-05	HUMAN PRESCRIPTION DRUG LABEL	8