ATORVASTATIN CALCIUM

Product NDC: 50268-093
11-digit product format: 502680093
Labeler code: 50268
Product ID: 50268-093_4dc870e1-0b0c-9b87-e063-6294a90a1845
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATORVASTATIN CALCIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvPAK
Application: ANDA090548
Marketing category: ANDA
Marketing start: 2016-06-28
Substance: ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Active strength: 10 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 1.

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
A090548-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29
A090548-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29
A090548-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29
A090548-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090548-001	AB
A090548-002	AB
A090548-003	AB
A090548-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A090548-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090548-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090548-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090548-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	52d8508b-aa98-cd89-5991-e2b5f982b6c6	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	303989c9-823e-4bcb-a7b3-7024fd0d3a38	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	e91c673d-c26c-4ff1-90d2-2b9d47a8d771	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	d57720ab-9f83-4da9-a57f-0d55e00a605c	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Unit Dose Solutions, Inc.	53c06fa9-ec26-5fa6-e063-6294a90a337f	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	75ea68e0-12e2-4e27-876f-f24f6e33a0b7	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	ed57fc60-ecb2-419e-b09f-3c518dcf3d04	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	1272aada-9a5b-4397-bb65-9398927aa325	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	ed0d5c17-0481-4d6b-8051-8d6e47f49ce5	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	AvPAK	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548 ndc (product): 50268-093
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	4a2bad30-e7cf-c48a-e063-6294a90a5f47	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	09c6c750-ae05-459f-83e8-4a9e4fd85212	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	f32c8a4f-dee9-86a0-e053-2995a90a3388	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	f76b9e48-3ef7-e15a-e053-6394a90aed58	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	0e10adb3-8d3a-412f-ae56-d9b9bed4641f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	0c5823ce-ed5c-356c-e063-6394a90aa15d	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	QPharma, Inc.	f7cc5704-2131-4bcb-9ff0-33a79a8167bd	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	QPharma, Inc.	d8a72abf-1d43-47e1-88e8-c3c5cc4ba163	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	7353f9ef-6f79-4522-886a-7a8ae4eb867e	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	e74278b6-31fc-48d4-97b7-ba500e9e15fb	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548

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 PROPYLENE GLYCOL SOLVATE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YRZ789OWMI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
259255	Internal RxNorm lookup
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
b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	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
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
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
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
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
50268-093-15	2022-01-31	C162847	48780-1	d6a99b39-ed9c-a426-e053-dadaa90af4c2	Atorvastatin Calcium Tablets Rx Only 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
50268-093-15	2022-01-31	C162847	48780-1	d6a99b39-ed9c-a426-e053-dadaa90af4c2	Atorvastatin Calcium Tablets Rx Only 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
50268-093-15	2022-01-28	C162847	48780-1	d6a99b39-ed9c-a426-e053-dadaa90af4c2	Atorvastatin Calcium Tablets Rx Only 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
50268-093-15	2022-01-28	C162847	48780-1	d6a99b39-ed9c-a426-e053-dadaa90af4c2	Atorvastatin Calcium Tablets Rx Only 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
50268-093-11	ATORVASTATIN CALCIUM	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		10
50268-093-15	ATORVASTATIN CALCIUM	50 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	50		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-093	ATORVASTATIN CALCIUM TABLET, FILM COATED [AVPAK]	8	Current NDC, Legacy NDC, 2 package rows	20240110_b687ba81-cb24-bbdf-5dd9-ab0e53dd480b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YRZ789OWMI	ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE	1040350-07-9	ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	10
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	10
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	10
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	10
617312	atorvastatin 10 MG Oral Tablet	SCD	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	10
617310	atorvastatin 20 MG Oral Tablet	SCD	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	10
617311	atorvastatin 40 MG Oral Tablet	SCD	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	10
259255	atorvastatin 80 MG Oral Tablet	SCD	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	10
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	10
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	10
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	10
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-093-11	50268009311	1 in 1 BLISTER PACK						Historical
50268-093-15	50268009315	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-093-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-093-11)	50 blister pack	2016-06-28	0000-00-00	No	No	Current