FloLipid

Product NDC
29273-401
11-digit product format
292730401
Labeler code
29273
Product ID
29273-401_d733a50e-32b3-2d73-e053-2a95a90a6106
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Salerno Pharmaceuticals Co.
Application
NDA206679
Marketing category
NDA
Marketing start
2017-11-01
Marketing end
0000-00-00
Substance
SIMVASTATIN
Active strength
20 mg/5mL
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct29273-401IInactivated by FDA2026-10-16
excluded packagepackage29273-40129273-401-04IInactivated by FDA2026-10-16

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage29273-401-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage29273-401-04f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206679-001FLOLIPIDSIMVASTATIN20MG/5MLSUSPENSION / ORALRLD2016-04-21
N206679-002FLOLIPIDSIMVASTATIN40MG/5MLSUSPENSION / ORALRLD, RS2016-04-21

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206679-001103000412027-04-26Drug product2019-10-18
N206679-00195972892030-02-23Drug product2017-04-21
N206679-002103000412027-04-26Drug product2019-10-18
N206679-00295972892030-02-23Drug product2017-04-21

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-21c2088c7a36db…
2026-10-15 13:18:302026-09N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-21c2088c7a36db…
2026-09-14 22:38:342026-08N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-2184e616aacf4f…
2026-09-14 22:38:342026-08N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-2184e616aacf4f…
2026-08-18 06:07:402026-07N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-21caaa826d4ba7…
2026-08-18 06:07:402026-07N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206679-001FLOLIPID20MG/5MLSUSPENSION / ORALRLD2016-04-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N206679-002FLOLIPID40MG/5MLSUSPENSION / ORALRLD, RS2016-04-214b0b4de00fa7…

Observed Orange Book patent history#

Patent history page 1 of 5 · 174 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N206679-001103000412027-04-26Drug product2019-10-18c2088c7a36db…
2026-10-15 13:18:302026-09N206679-00195972892030-02-23Drug product2017-04-21c2088c7a36db…
2026-10-15 13:18:302026-09N206679-002103000412027-04-26Drug product2019-10-18c2088c7a36db…
2026-10-15 13:18:302026-09N206679-00295972892030-02-23Drug product2017-04-21c2088c7a36db…
2026-09-14 22:38:342026-08N206679-001103000412027-04-26Drug product2019-10-1884e616aacf4f…
2026-09-14 22:38:342026-08N206679-00195972892030-02-23Drug product2017-04-2184e616aacf4f…
2026-09-14 22:38:342026-08N206679-002103000412027-04-26Drug product2019-10-1884e616aacf4f…
2026-09-14 22:38:342026-08N206679-00295972892030-02-23Drug product2017-04-2184e616aacf4f…
2026-08-18 06:07:402026-07N206679-001103000412027-04-26Drug product2019-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N206679-00195972892030-02-23Drug product2017-04-21caaa826d4ba7…
2026-08-18 06:07:402026-07N206679-002103000412027-04-26Drug product2019-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N206679-00295972892030-02-23Drug product2017-04-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206679-001103000412027-04-26Drug product2019-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206679-00195972892030-02-23Drug product2017-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206679-002103000412027-04-26Drug product2019-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206679-00295972892030-02-23Drug product2017-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206679-001103000412027-04-26Drug product2019-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206679-00195972892030-02-23Drug product2017-04-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206679-002103000412027-04-26Drug product2019-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206679-00295972892030-02-23Drug product2017-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N206679-001103000412027-04-26Drug product2019-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206679-00195972892030-02-23Drug product2017-04-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206679-002103000412027-04-26Drug product2019-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206679-00295972892030-02-23Drug product2017-04-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206679-001103000412027-04-26Drug product2019-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206679-00195972892030-02-23Drug product2017-04-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206679-002103000412027-04-26Drug product2019-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206679-00295972892030-02-23Drug product2017-04-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206679-001103000412027-04-26Drug product2019-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206679-00195972892030-02-23Drug product2017-04-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206679-002103000412027-04-26Drug product2019-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206679-00295972892030-02-23Drug product2017-04-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206679-001103000412027-04-26Drug product2019-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206679-00195972892030-02-23Drug product2017-04-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206679-002103000412027-04-26Drug product2019-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206679-00295972892030-02-23Drug product2017-04-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206679-001103000412027-04-26Drug product2019-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206679-00195972892030-02-23Drug product2017-04-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206679-002103000412027-04-26Drug product2019-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206679-00295972892030-02-23Drug product2017-04-212680178bc6a6…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29273-401-04FloLipid150 mL in 1 BOTTLE, GLASSSUSPENSION1506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29273-401-04ML - Milliliter29273-401424ac3cf-ae74-4c82-8f0c-982525f3231e12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29273-401FLOLIPID (SIMVASTATIN) SUSPENSION [SALERNO PHARMACEUTICALS CO.]6Legacy NDC, 1 package rows20230210_6ee17d10-6eb1-452a-99e8-02381368b3fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1944262FloLipid 20 MG in 5 mL Oral SuspensionPSN6ee17d10-6eb1-452a-99e8-02381368b3fe6
1944266FloLipid 40 MG in 5 mL Oral SuspensionPSN6ee17d10-6eb1-452a-99e8-02381368b3fe6
1790679simvastatin 20 MG in 5 mL Oral SuspensionPSN6ee17d10-6eb1-452a-99e8-02381368b3fe6
1944264simvastatin 40 MG in 5 mL Oral SuspensionPSN6ee17d10-6eb1-452a-99e8-02381368b3fe6
1944262simvastatin 4 MG/ML Oral Suspension [Flolipid]SBD6ee17d10-6eb1-452a-99e8-02381368b3fe6
1944266simvastatin 8 MG/ML Oral Suspension [Flolipid]SBD6ee17d10-6eb1-452a-99e8-02381368b3fe6
1790679simvastatin 4 MG/ML Oral SuspensionSCD6ee17d10-6eb1-452a-99e8-02381368b3fe6
1944264simvastatin 8 MG/ML Oral SuspensionSCD6ee17d10-6eb1-452a-99e8-02381368b3fe6
1944262Flolipid 20 MG per 5 mL Oral SuspensionSY6ee17d10-6eb1-452a-99e8-02381368b3fe6
1944262Flolipid 4 MG/ML Oral SuspensionSY6ee17d10-6eb1-452a-99e8-02381368b3fe6
1944266Flolipid 40 MG per 5 mL Oral SuspensionSY6ee17d10-6eb1-452a-99e8-02381368b3fe6
1944266Flolipid 8 MG/ML Oral SuspensionSY6ee17d10-6eb1-452a-99e8-02381368b3fe6
1790679simvastatin 20 MG per 5 ML Oral SuspensionSY6ee17d10-6eb1-452a-99e8-02381368b3fe6
1944264simvastatin 40 MG per 5 mL Oral SuspensionSY6ee17d10-6eb1-452a-99e8-02381368b3fe6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29273-401-0429273040104150 mL in 1 BOTTLE, GLASS (29273-401-04) 150 ml2017-11-010000-00-00NoNoCurrent