Atorvastatin Calcium

Product NDC
71335-2388
Requested package NDC
71335-2388-5
11-digit product format
713352388
Labeler code
71335
Product ID
71335-2388_351d59d0-e7fd-a0c6-e063-6394a90ab9ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium, film coated
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209912
Marketing category
ANDA
Marketing start
2023-10-20
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209912-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-18
A209912-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-18
A209912-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-18
A209912-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209912-001AB
A209912-002AB
A209912-003AB
A209912-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-1884e616aacf4f…
2026-09-14 22:38:342026-08A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-1884e616aacf4f…
2026-09-14 22:38:342026-08A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-1884e616aacf4f…
2026-09-14 22:38:342026-08A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-1884e616aacf4f…
2026-08-18 06:07:402026-07A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-18caaa826d4ba7…
2026-08-18 06:07:402026-07A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-18caaa826d4ba7…
2026-08-18 06:07:402026-07A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-18caaa826d4ba7…
2026-08-18 06:07:402026-07A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-185bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209912-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A209912-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A209912-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A209912-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A209912-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209912-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209912-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209912-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209912-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209912-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209912-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209912-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209912-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209912-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209912-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209912-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-004AB15bbf6a4d5a75…

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
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
48A5M73Z4QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
617312Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b8fa04f5-0d56-49ca-bb01-f0dd3b472164Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2388-1Atorvastatin Calcium30 in 1 BOTTLETABLET302
71335-2388-2Atorvastatin Calcium90 in 1 BOTTLETABLET902
71335-2388-3Atorvastatin Calcium60 in 1 BOTTLETABLET602
71335-2388-4Atorvastatin Calcium120 in 1 BOTTLETABLET1202
71335-2388-5Atorvastatin Calcium100 in 1 BOTTLETABLET1002
71335-2388-6Atorvastatin Calcium180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2388-2EA - Each71335-238879555c97-36d5-4520-8a26-f0546abf737712025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2388ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM, FILM COATED) TABLET [BRYANT RANCH PREPACK]2Current NDC, 6 package rows20250516_b8fa04f5-0d56-49ca-bb01-f0dd3b472164.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDPreferred Pharmaceuticals Inc.a92f2742-1763-4a02-94b7-e8db714eb2f42026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDNuCare Pharmaceuticals, Inc.4344f574-9b86-7ae5-e063-6294a90a79e82025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDPreferred Pharmaceuticals Inc.7fc58ce3-f069-409b-b36f-bb23ce21fb6f2025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDNuCare Pharmaceuticals, Inc.3ef3b6e3-83dc-e06a-e063-6394a90a152c2025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDRising Pharma Holdings, Inc.73cefb0b-1747-4fe0-b252-377f4ed94c6f2025-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDNuCare Pharmaceuticals, Inc.3bde7950-3d25-a86e-e063-6394a90ae6232025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDBryant Ranch Prepack9c58c4cd-fe1c-4db7-832c-874766e4da212025-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDNuCare Pharmaceuticals,Inc.3778125d-b3d9-2853-e063-6394a90aa8632025-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDBryant Ranch Prepackb8fa04f5-0d56-49ca-bb01-f0dd3b4721642025-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
ndc (package): 71335-2388-5
ndc (product): 71335-2388
ndc11 (package): 71335238805
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDBryant Ranch Prepack17f779f2-48ac-4719-bf37-0ee162f911442025-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDPreferred Pharmaceuticals Inc.bb825db4-3798-4d69-8559-46b3ab0c8bd92025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
atorvastatin calciumATORVASTATIN CALCIUM, FILM COATEDNuCare Pharmaceuticals,Inc.faba7fc1-2e08-74ef-e053-6394a90afd042025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
atorvastatin calciumATORVASTATIN CALCIUM, FILM COATEDNuCare Pharmaceuticals,Inc.0a9d4e36-305a-2120-e063-6294a90a01bd2025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDBryant Ranch Prepack32b40825-6b0b-4025-86f5-b4e453efea922024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNb8fa04f5-0d56-49ca-bb01-f0dd3b4721642
617312atorvastatin 10 MG Oral TabletSCDb8fa04f5-0d56-49ca-bb01-f0dd3b4721642
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYb8fa04f5-0d56-49ca-bb01-f0dd3b4721642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2388-571335238805100 TABLET in 1 BOTTLE (71335-2388-5) 100 tablet2024-05-29NoNoCurrent