Atorvastatin Calcium

Product NDC: 60760-829
11-digit product format: 607600829
Labeler code: 60760
Product ID: 60760-829_ef53a855-a5df-8e3e-e053-2a95a90a19f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: ST. MARY'S MEDICAL PARK PHARMACY
Application: ANDA076477
Marketing category: ANDA
Marketing start: 2022-11-08
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60760-829		D	Discontinued by firm		2026-10-15
excluded package	package	60760-829	60760-829-30	D	Discontinued by firm		2026-10-15

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-829-30	EA - Each	60760-829	0f2f7cfa-c481-4278-8440-b9a065cdfd6a	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-829	ATORVASTATIN CALCIUM TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]	1	Legacy NDC	20221209_ef53a017-5a66-2334-e053-2995a90ae593.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60760-829-30	60760082930	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-829-30)	2022-11-08	0000-00-00	No	No	Current