ATORVASTATIN CALCIUM

Product NDC
61919-303
Requested package NDC
61919-303-90
11-digit product format
619190303
Labeler code
61919
Product ID
61919-303_b8556fd4-1769-6175-e053-2995a90aaf6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090548
Marketing category
ANDA
Marketing start
2018-11-09
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
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-30361919-303-90IInactivated by FDA2026-08-11

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A090548-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29
A090548-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29
A090548-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29
A090548-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29

Therapeutic equivalence codes#

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

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

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 UTC2026-02A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29d06236e962d9…

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 UTC2026-02A090548-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090548-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090548-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090548-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090548-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090548-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090548-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090548-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090548-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090548-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090548-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090548-004AB1d06236e962d9…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-303-902023-01-30C16284748780-1f386c649-9e9b-0266-e053-dadaa90a7c1aATORVASTATIN CALCIUM
61919-303-302020-01-31C16284748780-19d75b9d0-c148-f424-e053-dadaa90a57ceATORVASTATIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-303-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED903
61919-303-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-303-30EA - Each61919-303576da26d-c93b-4e91-ba82-a7f415545a5712018-04-19
61919-303-90EA - Each61919-3032ee6c746-1e4e-4bd1-b7d1-bdfb53618ace12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-303ATORVASTATIN CALCIUM (ATORVASTATIN) TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 package rows20210108_7a3d0c78-f0a7-0706-e053-2991aa0ae9f7.zip
61919-303ATORVASTATIN CALCIUM (ATORVASTATIN) TABLET, FILM COATED [DIRECT RX]2Legacy NDC, 1 package rows20180315_339af810-2a32-0804-e054-00144ff8d46c.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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor Pharmaceuticalse74278b6-31fc-48d4-97b7-ba500e9e15fb2026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNORTHSTAR RX LLC52d8508b-aa98-cd89-5991-e2b5f982b6c62026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.303989c9-823e-4bcb-a7b3-7024fd0d3a382026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.e91c673d-c26c-4ff1-90d2-2b9d47a8d7712026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.d57720ab-9f83-4da9-a57f-0d55e00a605c2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMUnit Dose Solutions, Inc.53c06fa9-ec26-5fa6-e063-6294a90a337f2026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMCardinal Health 107, LLC75ea68e0-12e2-4e27-876f-f24f6e33a0b72026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMCardinal Health 107, LLCed57fc60-ecb2-419e-b09f-3c518dcf3d042026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMCardinal Health 107, LLC1272aada-9a5b-4397-bb65-9398927aa3252026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
Atorvastatin CalciumATORVASTATIN CALCIUMCardinal Health 107, LLCed0d5c17-0481-4d6b-8051-8d6e47f49ce52026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAvPAKb687ba81-cb24-bbdf-5dd9-ab0e53dd480b2026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.4a2bad30-e7cf-c48a-e063-6294a90a5f472026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.09c6c750-ae05-459f-83e8-4a9e4fd852122026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNorthwind Health Company, LLCf32c8a4f-dee9-86a0-e053-2995a90a33882026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNorthwind Health Company, LLCf76b9e48-3ef7-e15a-e053-6394a90aed582026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNorthwind Health Company, LLC0e10adb3-8d3a-412f-ae56-d9b9bed4641f2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNorthwind Health Company, LLC0c5823ce-ed5c-356c-e063-6394a90aa15d2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQPharma, Inc.f7cc5704-2131-4bcb-9ff0-33a79a8167bd2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQPharma, Inc.d8a72abf-1d43-47e1-88e8-c3c5cc4ba1632025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, LLC dba Vangard Labs7353f9ef-6f79-4522-886a-7a8ae4eb867e2025-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN7a3d0c78-f0a7-0706-e053-2991aa0ae9f73
617311atorvastatin 40 MG Oral TabletSCD7a3d0c78-f0a7-0706-e053-2991aa0ae9f73
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY7a3d0c78-f0a7-0706-e053-2991aa0ae9f73
617311atorvastatin calcium 40 MG Oral TabletPSN339af810-2a32-0804-e054-00144ff8d46c2
617311atorvastatin 40 MG Oral TabletSCD339af810-2a32-0804-e054-00144ff8d46c2
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY339af810-2a32-0804-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-303-906191903039090 TABLET, FILM COATED in 1 BOTTLE (61919-303-90) 2018-11-090000-00-00NoNoCurrent