Home NDC 27437-051-02 SOLOSEC
Product NDC 27437-051
Requested package NDC 27437-051-02
11-digit product format 274370051
Labeler code 27437
Product ID 27437-051_fe8dadfb-2b46-433c-b3fa-9d9c3d0548b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name secnidazole
Dosage form GRANULE
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application NDA209363
Marketing category NDA
Marketing start 2017-10-30
Marketing end 0000-00-00
Substance SECNIDAZOLE
Active strength 2 g/4.8g
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 27437-051 27437-051-02 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 27437-051 27437-051-02 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209363-001 SOLOSEC SECNIDAZOLE 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15
Orange Book patents# Current patent rows page 1 of 1 · 33 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209363-001 10335390 2035-09-04 U-2583 Drug product 2019-07-31 N209363-001 10335390 2035-09-04 U-3270 Drug product 2019-07-31 N209363-001 10682338 2035-09-04 U-2583 Drug product 2020-06-23 N209363-001 10682338 2035-09-04 U-3270 Drug product 2020-06-23 N209363-001 10849884 2035-09-04 U-2583 Drug product 2020-12-11 N209363-001 10849884 2035-09-04 U-3169 Drug product 2020-12-11 N209363-001 10849884 2035-09-04 U-3270 Drug product 2020-12-11 N209363-001 10849884 2035-09-04 U-3302 Drug product 2020-12-11 N209363-001 10857133 2035-09-04 U-2583 Drug product 2020-12-11 N209363-001 10857133 2035-09-04 U-3270 Drug product 2020-12-11 N209363-001 11000507 2035-09-04 U-2583 Drug product 2021-06-07 N209363-001 11000507 2035-09-04 U-3169 Drug product 2021-06-07 N209363-001 11000507 2035-09-04 U-3270 Drug product 2021-06-07 N209363-001 11000507 2035-09-04 U-3302 Drug product 2021-06-07 N209363-001 11000508 2035-09-04 U-2583 Drug product 2021-06-07 N209363-001 11000508 2035-09-04 U-3169 Drug product 2021-06-07 N209363-001 11000508 2035-09-04 U-3270 Drug product 2021-06-07 N209363-001 11000508 2035-09-04 U-3302 Drug product 2021-06-07 N209363-001 11020377 2035-09-04 U-2583 Drug product 2021-06-16 N209363-001 11020377 2035-09-04 U-3169 Drug product 2021-06-16 N209363-001 11020377 2035-09-04 U-3270 Drug product 2021-06-16 N209363-001 11020377 2035-09-04 U-3302 Drug product 2021-06-16 N209363-001 11324721 2035-09-04 U-2583 Drug product 2022-05-18 N209363-001 11324721 2035-09-04 U-3169 Drug product 2022-05-18 N209363-001 11324721 2035-09-04 U-3270 Drug product 2022-05-18 N209363-001 11324721 2035-09-04 U-3302 Drug product 2022-05-18 N209363-001 11602522 2035-09-04 U-3169 Drug product 2023-03-27 N209363-001 11602522 2035-09-04 U-3302 Drug product 2023-03-27 N209363-001 11684607 2035-09-16 U-2583 Drug product 2023-07-07 N209363-001 11684607 2035-09-16 U-3169 Drug product 2023-07-07 N209363-001 11684607 2035-09-16 U-3270 Drug product 2023-07-07 N209363-001 11684607 2035-09-16 U-3302 Drug product 2023-07-07 N209363-001 12280037 2041-12-11 U-3302 2025-05-19
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N209363-001 NCE 2022-09-15 N209363-001 GAIN 2027-09-15
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 2 · 44 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 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 3a93d1ddd44b…
Observed Orange Book patent history# Patent history page 1 of 27 · 1,068 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 N209363-001 10335390 2035-09-04 U-2583 Drug product 2019-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 10335390 2035-09-04 U-3270 Drug product 2019-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 10682338 2035-09-04 U-3270 Drug product 2020-06-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 10682338 2035-09-04 U-2583 Drug product 2020-06-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 10849884 2035-09-04 U-3270 Drug product 2020-12-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 10849884 2035-09-04 U-3302 Drug product 2020-12-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 10849884 2035-09-04 U-3169 Drug product 2020-12-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 10849884 2035-09-04 U-2583 Drug product 2020-12-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 10857133 2035-09-04 U-3270 Drug product 2020-12-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 10857133 2035-09-04 U-2583 Drug product 2020-12-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11000507 2035-09-04 U-3302 Drug product 2021-06-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11000507 2035-09-04 U-3270 Drug product 2021-06-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11000507 2035-09-04 U-3169 Drug product 2021-06-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11000507 2035-09-04 U-2583 Drug product 2021-06-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11000508 2035-09-04 U-3302 Drug product 2021-06-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11000508 2035-09-04 U-3270 Drug product 2021-06-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11000508 2035-09-04 U-3169 Drug product 2021-06-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11000508 2035-09-04 U-2583 Drug product 2021-06-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11020377 2035-09-04 U-3302 Drug product 2021-06-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11020377 2035-09-04 U-3270 Drug product 2021-06-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11020377 2035-09-04 U-3169 Drug product 2021-06-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11020377 2035-09-04 U-2583 Drug product 2021-06-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11324721 2035-09-04 U-2583 Drug product 2022-05-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11324721 2035-09-04 U-3169 Drug product 2022-05-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11324721 2035-09-04 U-3270 Drug product 2022-05-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11324721 2035-09-04 U-3302 Drug product 2022-05-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11602522 2035-09-04 U-3169 Drug product 2023-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11602522 2035-09-04 U-3302 Drug product 2023-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11684607 2035-09-16 U-2583 Drug product 2023-07-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11684607 2035-09-16 U-3169 Drug product 2023-07-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11684607 2035-09-16 U-3270 Drug product 2023-07-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 11684607 2035-09-16 U-3302 Drug product 2023-07-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209363-001 12280037 2041-12-11 U-3302 2025-05-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 N209363-001 10335390 2035-09-04 U-2583 Drug product 2019-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209363-001 10335390 2035-09-04 U-3270 Drug product 2019-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209363-001 10682338 2035-09-04 U-3270 Drug product 2020-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209363-001 10682338 2035-09-04 U-2583 Drug product 2020-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209363-001 10849884 2035-09-04 U-3270 Drug product 2020-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209363-001 10849884 2035-09-04 U-3302 Drug product 2020-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209363-001 10849884 2035-09-04 U-3169 Drug product 2020-12-11 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 144 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27437-051 SOLOSEC (SECNIDAZOLE) GRANULE [LUPIN PHARMACEUTICALS, INC.] 14 Legacy NDC 20220727_551e43d5-f700-4d6e-8029-026f8a8932ff.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 27437-051-02 27437005102 1 PACKET in 1 BOX, UNIT-DOSE (27437-051-02) > 2 g in 1 PACKET 1 packet 2019-03-19 0000-00-00 No No Current