Atorvastatin Calcium

Product NDC: 67296-1422
11-digit product format: 672961422
Labeler code: 67296
Product ID: 67296-1422_bb684f3a-f31a-0e45-e053-2a95a90ac410
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA076477
Marketing category: ANDA
Marketing start: 2021-02-15
Marketing end: 0000-00-00
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67296-1422		I	Inactivated by FDA		2026-10-15
excluded package	package	67296-1422	67296-1422-3	I	Inactivated by FDA		2026-10-15

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1422-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1422-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1422-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1422-3	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A076477-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2011-11-30
A076477-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2011-11-30
A076477-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2011-11-30
A076477-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2011-11-30

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 · 176 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
2026-10-15 13:18:30	2026-09	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A076477-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076477-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076477-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076477-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076477-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076477-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076477-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076477-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076477-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076477-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076477-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076477-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076477-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076477-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076477-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076477-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076477-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076477-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076477-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076477-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076477-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076477-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076477-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076477-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076477-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076477-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076477-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076477-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076477-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076477-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076477-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076477-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076477-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076477-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076477-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076477-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076477-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076477-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076477-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076477-004	AB	1	`8869cabd3fbd…`

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
67296-1422-3	2026-01-29	C162847	48780-1	f386c649-ab74-0266-e053-dadaa90a7c1a	ATORVASTATIN 20mg tab
67296-1422-3	2024-08-07	C162847	48780-1	f386c649-ab74-0266-e053-dadaa90a7c1a	ATORVASTATIN 20mg tab
67296-1422-3	2023-01-30	C162847	48780-1	f386c649-ab74-0266-e053-dadaa90a7c1a	ATORVASTATIN 20mg tab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1422-3	Atorvastatin Calcium	30 in 1 BOTTLE	TABLET, FILM COATED	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1422	ATORVASTATIN CALCIUM TABLET, FILM COATED [REDPHARM DRUG, INC.]	5	Legacy NDC, 1 package rows	20240808_bb684dda-15a4-6e6b-e053-2a95a90a8e53.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	2e583569-499d-4f20-87ca-84e7d9868d22	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Sun Pharmaceutical Industries Inc.	595ab888-6b55-4642-a32f-e8521821ed81	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	49dcc58a-9f23-045d-e063-6394a90abda6	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	DIRECT RX	c3b70f79-45a3-0869-e053-2a95a90a3cdb	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	f7af3b3a-b73e-41ee-80e3-2be036672bb7	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	b1a840cf-47aa-b931-e053-2a95a90a1047	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	bbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	d77e155c-403d-449e-bafd-11c9bd4974dd	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477

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
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	bb684dda-15a4-6e6b-e053-2a95a90a8e53	5
617310	atorvastatin 20 MG Oral Tablet	SCD	bb684dda-15a4-6e6b-e053-2a95a90a8e53	5
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	bb684dda-15a4-6e6b-e053-2a95a90a8e53	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1422-3	67296142203	30 TABLET, FILM COATED in 1 BOTTLE (67296-1422-3)	2021-02-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATORVASTATIN 20mg tab	RedPharm Drug, Inc. \| RedPharm Drug	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	5