Home NDC 24208-377 MIEBO
Product NDC 24208-377
11-digit product format 242080377
Labeler code 24208
Product ID 24208-377_4cb37a53-376f-ef57-e063-6294a90a5bf8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Perfluorohexyloctane
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Bausch & Lomb Incorporated
Application NDA216675
Marketing category NDA
Marketing start 2023-05-18
Substance PERFLUOROHEXYLOCTANE
Active strength 1 mg/mg
Pharmacologic classes Semifluorinated Alkane [EPC], Semifluorinated Alkane [EXT]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N216675-001 MIEBO PERFLUOROHEXYLOCTANE 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216675-001 10058615 2033-09-12 U-1900 2023-06-08 N216675-001 10369117 2033-09-12 U-1900 2023-06-08 N216675-001 10449164 2033-09-12 U-1900 2023-06-08 N216675-001 12005033 2033-09-12 U-4586 2026-08-20 N216675-001 10576154 2035-10-01 U-1900 2023-06-08 N216675-001 10682315 2036-09-29 U-4586 2026-08-20 N216675-001 11357738 2036-09-29 Drug product 2023-06-08 N216675-001 12128010 2036-09-29 Drug product 2026-08-20 N216675-001 10507132 2037-06-21 U-1900 2023-06-08 N216675-001 RE50060 2037-06-21 U-4586 2026-08-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216675-001 NCE 2028-05-18
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.
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 2026-09-14 22:38:34 2026-08 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216675-001 MIEBO 1.338GM/ML SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-05-18 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 142 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N216675-001 10058615 2033-09-12 U-1900 2023-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216675-001 10369117 2033-09-12 U-1900 2023-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216675-001 10449164 2033-09-12 U-1900 2023-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216675-001 12005033 2033-09-12 U-4586 2026-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216675-001 10576154 2035-10-01 U-1900 2023-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216675-001 10682315 2036-09-29 U-4586 2026-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216675-001 11357738 2036-09-29 Drug product 2023-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216675-001 12128010 2036-09-29 Drug product 2026-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216675-001 10507132 2037-06-21 U-1900 2023-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216675-001 RE50060 2037-06-21 U-4586 2026-08-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216675-001 10058615 2033-09-12 U-1900 2023-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216675-001 10369117 2033-09-12 U-1900 2023-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216675-001 10449164 2033-09-12 U-1900 2023-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216675-001 10576154 2035-10-01 U-1900 2023-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216675-001 11357738 2036-09-29 Drug product 2023-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216675-001 10507132 2037-06-21 U-1900 2023-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216675-001 10058615 2033-09-12 U-1900 2023-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216675-001 10369117 2033-09-12 U-1900 2023-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216675-001 10449164 2033-09-12 U-1900 2023-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216675-001 10576154 2035-10-01 U-1900 2023-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216675-001 11357738 2036-09-29 Drug product 2023-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216675-001 10507132 2037-06-21 U-1900 2023-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216675-001 10058615 2033-09-12 U-1900 2023-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216675-001 10369117 2033-09-12 U-1900 2023-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216675-001 10449164 2033-09-12 U-1900 2023-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216675-001 10576154 2033-09-12 U-1900 2023-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216675-001 11357738 2036-09-29 Drug product 2023-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216675-001 10507132 2037-06-21 U-1900 2023-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216675-001 10058615 2033-09-12 U-1900 2023-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216675-001 10369117 2033-09-12 U-1900 2023-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216675-001 10449164 2033-09-12 U-1900 2023-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216675-001 10576154 2033-09-12 U-1900 2023-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216675-001 11357738 2036-09-29 Drug product 2023-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216675-001 10507132 2037-06-21 U-1900 2023-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216675-001 10058615 2033-09-12 U-1900 2023-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216675-001 10369117 2033-09-12 U-1900 2023-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216675-001 10449164 2033-09-12 U-1900 2023-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216675-001 10576154 2033-09-12 U-1900 2023-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216675-001 11357738 2036-09-29 Drug product 2023-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216675-001 10507132 2037-06-21 U-1900 2023-06-08 fd3edfee7708…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base MIEBO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PERFLUOROHEXYLOCTANE 1 mg/mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7VYX4ELWQM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2637551 Internal RxNorm lookup 2637556 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24208-377 MIEBO (PERFLUOROHEXYLOCTANE) SOLUTION [BAUSCH & LOMB INCORPORATED] 10 Current NDC, 6 package rows 20240719_6b283c02-7df4-4c00-951b-555cddffe77c.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MIEBO PERFLUOROHEXYLOCTANE Bausch & Lomb Incorporated 6b283c02-7df4-4c00-951b-555cddffe77c 2026-03-10 Warnings, Adverse reactions Exact identifier application applno (NDA): 216675 application number: NDA216675 ndc (product): 24208-377
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 24208-377-01 24208037701 1 BOTTLE in 1 CARTON (24208-377-01) / 3 mg in 1 BOTTLE 1 bottle 2023-05-18 Yes No Current 24208-377-05 24208037705 1 BOTTLE in 1 CARTON (24208-377-05) / 3 mg in 1 BOTTLE 1 bottle 2023-05-18 No No Current 24208-377-06 24208037706 1 BOTTLE in 1 CARTON (24208-377-06) / 1.6 mg in 1 BOTTLE 1 bottle 2024-07-19 Yes No Current