Atorvastatin Calcium

Product NDC: 68788-8625
Requested package NDC: 68788-8625-3
11-digit product format: 687888625
Labeler code: 68788
Product ID: 68788-8625_0f633003-ea4c-45fe-bfd8-9838e31ebb8b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atorvastatin calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA216436
Marketing category: ANDA
Marketing start: 2024-04-09
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: 2027-12-31
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
A216436-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2022-11-23
A216436-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2022-11-23
A216436-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2022-11-23
A216436-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2022-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216436-001	AB
A216436-002	AB
A216436-003	AB
A216436-004	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 3 · 104 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	A216436-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2022-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216436-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2022-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216436-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2022-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216436-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2022-11-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216436-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2022-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216436-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2022-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216436-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2022-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216436-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2022-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216436-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2022-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216436-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2022-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216436-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2022-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216436-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2022-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216436-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2022-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216436-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2022-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216436-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2022-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216436-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2022-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216436-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2022-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216436-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2022-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216436-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2022-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216436-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2022-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216436-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2022-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216436-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2022-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216436-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2022-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216436-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2022-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216436-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2022-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216436-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2022-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216436-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2022-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216436-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2022-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216436-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2022-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216436-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2022-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216436-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2022-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216436-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2022-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216436-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2022-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216436-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2022-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216436-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2022-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216436-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2022-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216436-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2022-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216436-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2022-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216436-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2022-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216436-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2022-11-23	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 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	A216436-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216436-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216436-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216436-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216436-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216436-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216436-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216436-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216436-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216436-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216436-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216436-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216436-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216436-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216436-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216436-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216436-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216436-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216436-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216436-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216436-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216436-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216436-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216436-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216436-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216436-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216436-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216436-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216436-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216436-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216436-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216436-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216436-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216436-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216436-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216436-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216436-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216436-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216436-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216436-004	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: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
617310	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
6e6a3b6b-5536-434e-bd1d-7dc7256704ce	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-8625-1	Atorvastatin Calcium	100 in 1 BOTTLE	TABLET, FILM COATED	100	3
68788-8625-3	Atorvastatin Calcium	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
68788-8625-6	Atorvastatin Calcium	60 in 1 BOTTLE	TABLET, FILM COATED	60	3
68788-8625-9	Atorvastatin Calcium	90 in 1 BOTTLE	TABLET, FILM COATED	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8625-1	EA - Each	68788-8625	f5b190eb-e1df-43d4-a8b1-e91d6f57fc55	1	2024-06-10
68788-8625-3	EA - Each	68788-8625	4c177a41-ad1d-44a3-90ff-ca5c472c2af1	1	2024-06-10
68788-8625-6	EA - Each	68788-8625	bebd7317-6916-4dda-8baf-e6ba47380304	1	2024-06-10
68788-8625-9	EA - Each	68788-8625	dadfbf30-244d-4c50-9f3b-3545888c1482	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8625	ATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	2	Current NDC, 4 package rows	20250206_6e6a3b6b-5536-434e-bd1d-7dc7256704ce.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	St. Mary's Medical Park Pharmacy	149322ec-9ee6-2223-e063-6294a90a8aac	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216436 application number: ANDA216436
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	6e6a3b6b-5536-434e-bd1d-7dc7256704ce	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216436 application number: ANDA216436 ndc (package): 68788-8625-3 ndc (product): 68788-8625 ndc11 (package): 68788862503
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	2d9cb8d9-b367-464d-9bcd-6de8de2b6c23	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216436 application number: ANDA216436
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Biocon Pharma Inc.	5b839619-1805-c227-91bf-182f5b966ba4	2025-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216436 application number: ANDA216436
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	16c59ba4-1cb7-e23f-e063-6294a90a1683	2024-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216436 application number: ANDA216436
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	12751ca4-cde3-92dd-e063-6294a90a4e9d	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216436 application number: ANDA216436
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	f3af6315-08b5-4ff9-80ae-2984f0598611	2023-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216436 application number: ANDA216436

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	6e6a3b6b-5536-434e-bd1d-7dc7256704ce	3
617310	atorvastatin 20 MG Oral Tablet	SCD	6e6a3b6b-5536-434e-bd1d-7dc7256704ce	3
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	6e6a3b6b-5536-434e-bd1d-7dc7256704ce	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68788-8625-3	68788862503	30 TABLET, FILM COATED in 1 BOTTLE (68788-8625-3)	2024-04-09	No	No	Current