Atorvastatin calcium

Product NDC
70518-3339
Requested package NDC
70518-3339-0
11-digit product format
705183339
Labeler code
70518
Product ID
70518-3339_4ef3281a-e577-b5c2-e063-6394a90ad3f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA211933
Marketing category
ANDA
Marketing start
2022-01-23
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-333970518-3339-0DDiscontinued by firm2026-08-03

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 · 11 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-333970518-3339-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-333970518-3339-0DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-333970518-3339-0DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-333970518-3339-0DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-333970518-3339-0DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-333970518-3339-0DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-333970518-3339-0DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-333970518-3339-0DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-333970518-3339-0DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-333970518-3339-0DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-333970518-3339-0DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211933-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08
A211933-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08
A211933-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08
A211933-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211933-001AB
A211933-002AB
A211933-003AB
A211933-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211933-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211933-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211933-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Atorvastatin calcium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE20 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
617310Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b0bbab86-6789-4ffb-8f84-ee91b69fdb34Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3339-0Atorvastatin calcium30 in 1 BLISTER PACKTABLET, FILM COATED307
70518-3339-1Atorvastatin calcium30 in 1 BLISTER PACKTABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3339ATORVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 2 package rows20241004_b0bbab86-6789-4ffb-8f84-ee91b69fdb34.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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin calciumATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.52f99e39-fb92-e9f5-e063-6294a90a1b6a2026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.5b3c3043-9af6-48eb-8b10-528e58c88e482026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.51e24220-3374-4e5e-9a8d-4113002c5bed2026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.b0bbab86-6789-4ffb-8f84-ee91b69fdb342026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
ndc (package): 70518-3339-0
ndc (product): 70518-3339
ndc11 (package): 70518333900
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.9786388d-ac8d-4646-9fe4-b33e8fda86b22026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.e78ba844-97a6-4602-92b6-8190028b826d2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepackbf35034d-27ab-4263-a9ed-c7cee1a4fb0a2026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.21234914-e1bb-4118-8f81-4ab4a59e9e1e2026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin CalciumATORVASTATIN CALCIUMDirect_Rx124c111c-9272-eca9-e063-6394a90a0ad52026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMNorthwind Health Company, LLC13b1578a-70cc-6c58-e063-6394a90a0d1b2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepackec1d1722-d035-4a8b-b3ab-d2d93f2fd4bb2025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepackf1f3e4e0-5407-4831-9885-3a37e72356c02025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.4509aa67-06d4-41d1-80b6-c9bd8ad0bf072025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.46eeb12f-7e38-4828-b7d1-26b6155bc64a2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.e959b07b-3e6c-44cc-9a6d-c6689d393e4c2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepack00afce9b-48c9-487a-a738-e359c005c7072025-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.4ff0d618-cde4-49ae-8bcb-98dafc3ecdba2025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin CalciumATORVASTATIN CALCIUMDirect_rx1ade00fd-5eb4-f67a-e063-6294a90a91122025-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMProficient Rx LP9168df23-4260-46be-9556-8b037af0ea282025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.b490414a-35e7-fded-e053-2a95a90aca8d2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNb0bbab86-6789-4ffb-8f84-ee91b69fdb347
617310atorvastatin 20 MG Oral TabletSCDb0bbab86-6789-4ffb-8f84-ee91b69fdb347
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYb0bbab86-6789-4ffb-8f84-ee91b69fdb347

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3339-07051833390030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3339-0) 2022-01-230000-00-00NoNoCurrent