Home NDC 69751-400 Solosec
Product NDC 69751-400
11-digit product format 697510400
Labeler code 69751
Product ID 69751-400_4a3aa8e8-bb23-46ce-998d-69dc7c9fb386
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name secnidazole
Dosage form GRANULE
Route ORAL
Labeler Evofem Inc.
Application NDA209363
Marketing category NDA
Marketing start 2018-05-31
Substance SECNIDAZOLE
Active strength 2 g/4.8g
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 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 2026-08-18 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…2022-10-28 04:53 UTC 2022-10 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209363-001 SOLOSEC 2GM/PACKET GRANULE / ORAL RLD, RS 2017-09-15 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 26 · 1,002 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N209363-001 10335390 2035-09-04 U-2583 Drug product 2019-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10335390 2035-09-04 U-3270 Drug product 2019-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10682338 2035-09-04 U-3270 Drug product 2020-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10682338 2035-09-04 U-2583 Drug product 2020-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10849884 2035-09-04 U-3270 Drug product 2020-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10849884 2035-09-04 U-3302 Drug product 2020-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10849884 2035-09-04 U-3169 Drug product 2020-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10849884 2035-09-04 U-2583 Drug product 2020-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10857133 2035-09-04 U-3270 Drug product 2020-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 10857133 2035-09-04 U-2583 Drug product 2020-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000507 2035-09-04 U-3302 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000507 2035-09-04 U-3270 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000507 2035-09-04 U-3169 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000507 2035-09-04 U-2583 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000508 2035-09-04 U-3302 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000508 2035-09-04 U-3270 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000508 2035-09-04 U-3169 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11000508 2035-09-04 U-2583 Drug product 2021-06-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11020377 2035-09-04 U-3302 Drug product 2021-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11020377 2035-09-04 U-3270 Drug product 2021-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11020377 2035-09-04 U-3169 Drug product 2021-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11020377 2035-09-04 U-2583 Drug product 2021-06-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11324721 2035-09-04 U-2583 Drug product 2022-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11324721 2035-09-04 U-3169 Drug product 2022-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11324721 2035-09-04 U-3270 Drug product 2022-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11324721 2035-09-04 U-3302 Drug product 2022-05-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11602522 2035-09-04 U-3169 Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11602522 2035-09-04 U-3302 Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11684607 2035-09-16 U-2583 Drug product 2023-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11684607 2035-09-16 U-3169 Drug product 2023-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11684607 2035-09-16 U-3270 Drug product 2023-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 11684607 2035-09-16 U-3302 Drug product 2023-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209363-001 12280037 2041-12-11 U-3302 2025-05-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209363-001 10335390 2035-09-04 U-2583 Drug product 2019-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209363-001 10335390 2035-09-04 U-3270 Drug product 2019-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209363-001 10682338 2035-09-04 U-3270 Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209363-001 10682338 2035-09-04 U-2583 Drug product 2020-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209363-001 10849884 2035-09-04 U-3270 Drug product 2020-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209363-001 10849884 2035-09-04 U-3302 Drug product 2020-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209363-001 10849884 2035-09-04 U-3169 Drug product 2020-12-11 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 140 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Solosec
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SECNIDAZOLE 2 g/4.8g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R3459K699K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1946692 Internal RxNorm lookup 1946698 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69751-400-01 Solosec 2 g in 1 PACKET GRANULE 2 1 69751-400-01 Solosec 1 in 1 CARTON GRANULE 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69751-400 SOLOSEC (SECNIDAZOLE) GRANULE [EVOFEM INC.] 1 Current NDC, 2 package rows 20250223_056485b6-8bba-4a21-ae00-cdb4e7ae4bfa.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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69751-400-01 69751040001 1 PACKET in 1 CARTON (69751-400-01) / 2 g in 1 PACKET 1 packet 2018-05-31 No No Current