Home NDC 29273-402 FloLipid
Product NDC 29273-402
11-digit product format 292730402
Labeler code 29273
Product ID 29273-402_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 40 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
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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 29273-402-04 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 29273-402-04 f5e01cc5f278…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206679-001 FLOLIPID SIMVASTATIN 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 N206679-002 FLOLIPID SIMVASTATIN 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206679-001 10300041 2027-04-26 Drug product 2019-10-18 N206679-001 9597289 2030-02-23 Drug product 2017-04-21 N206679-002 10300041 2027-04-26 Drug product 2019-10-18 N206679-002 9597289 2030-02-23 Drug product 2017-04-21
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206679-001 FLOLIPID 20MG/5ML SUSPENSION / ORAL RLD 2016-04-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N206679-002 FLOLIPID 40MG/5ML SUSPENSION / ORAL RLD, RS 2016-04-21 4b0b4de00fa7…
Observed Orange Book patent history# Patent history page 1 of 5 · 174 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N206679-001 10300041 2027-04-26 Drug product 2019-10-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206679-001 9597289 2030-02-23 Drug product 2017-04-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206679-002 10300041 2027-04-26 Drug product 2019-10-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206679-002 9597289 2030-02-23 Drug product 2017-04-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 N206679-001 10300041 2027-04-26 Drug product 2019-10-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206679-001 9597289 2030-02-23 Drug product 2017-04-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206679-002 10300041 2027-04-26 Drug product 2019-10-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206679-002 9597289 2030-02-23 Drug product 2017-04-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206679-001 10300041 2027-04-26 Drug product 2019-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206679-001 9597289 2030-02-23 Drug product 2017-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206679-002 10300041 2027-04-26 Drug product 2019-10-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206679-002 9597289 2030-02-23 Drug product 2017-04-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206679-001 10300041 2027-04-26 Drug product 2019-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206679-001 9597289 2030-02-23 Drug product 2017-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206679-002 10300041 2027-04-26 Drug product 2019-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206679-002 9597289 2030-02-23 Drug product 2017-04-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206679-001 10300041 2027-04-26 Drug product 2019-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206679-001 9597289 2030-02-23 Drug product 2017-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206679-002 10300041 2027-04-26 Drug product 2019-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206679-002 9597289 2030-02-23 Drug product 2017-04-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206679-001 10300041 2027-04-26 Drug product 2019-10-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206679-001 9597289 2030-02-23 Drug product 2017-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206679-002 10300041 2027-04-26 Drug product 2019-10-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206679-002 9597289 2030-02-23 Drug product 2017-04-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206679-001 10300041 2027-04-26 Drug product 2019-10-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206679-001 9597289 2030-02-23 Drug product 2017-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206679-002 10300041 2027-04-26 Drug product 2019-10-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206679-002 9597289 2030-02-23 Drug product 2017-04-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206679-001 10300041 2027-04-26 Drug product 2019-10-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206679-001 9597289 2030-02-23 Drug product 2017-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206679-002 10300041 2027-04-26 Drug product 2019-10-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206679-002 9597289 2030-02-23 Drug product 2017-04-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206679-001 10300041 2027-04-26 Drug product 2019-10-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206679-001 9597289 2030-02-23 Drug product 2017-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206679-002 10300041 2027-04-26 Drug product 2019-10-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206679-002 9597289 2030-02-23 Drug product 2017-04-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206679-001 10300041 2027-04-26 Drug product 2019-10-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206679-001 9597289 2030-02-23 Drug product 2017-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206679-002 10300041 2027-04-26 Drug product 2019-10-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206679-002 9597289 2030-02-23 Drug product 2017-04-21 2680178bc6a6…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 29273-402-04 FloLipid 150 mL in 1 BOTTLE, GLASS SUSPENSION 150 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29273-402 FLOLIPID (SIMVASTATIN) SUSPENSION [SALERNO PHARMACEUTICALS CO.] 6 Legacy NDC, 1 package rows 20230210_6ee17d10-6eb1-452a-99e8-02381368b3fe.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 29273-402-04 29273040204 150 mL in 1 BOTTLE, GLASS (29273-402-04) 150 ml 2017-11-01 0000-00-00 No No Current