Home NDC 69794-050-50 DOJOLVI
Product NDC 69794-050
Requested package NDC 69794-050-50
11-digit product format 697940050
Labeler code 69794
Product ID 69794-050_a89d49c1-092a-4911-bbcc-611479f4c444
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triheptanoin
Dosage form LIQUID
Route ORAL
Labeler Ultragenyx Pharmaceutical Inc.
Application NDA213687
Marketing category NDA
Marketing start 2020-07-01
Substance TRIHEPTANOIN
Active strength .96 g/mL
Pharmacologic classes Medium-chain Triglyceride [EPC], Triglycerides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 1 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 2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 69794-050 69794-050-50 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
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 N213687-001 DOJOLVI TRIHEPTANOIN 100% w/w LIQUID / ORAL RLD, RS 2020-06-30
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213687-001 8697748 2029-04-28 Drug product 2020-10-02 N213687-001 12551461 2034-11-14 Drug product 2026-02-19
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213687-001 ODE-311 2027-06-30
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 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213687-001 DOJOLVI 100% w/w LIQUID / ORAL RLD, RS 2020-06-30 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 77 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 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213687-001 12551461 2034-11-14 Drug product 2026-02-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213687-001 12551461 2034-11-14 Drug product 2026-02-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213687-001 8697748 2029-04-28 Drug product 2020-10-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213687-001 8697748 2025-10-03 Drug product 2020-10-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N213687-001 8697748 2025-10-03 Drug product 2020-10-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N213687-001 8697748 2025-10-03 Drug product 2020-10-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N213687-001 8697748 2025-10-03 Drug product 2020-10-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213687-001 9186344 2025-07-01 Drug product 2020-10-02 782e0a99824c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 74 observed states.
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 DOJOLVI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIHEPTANOIN .96 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2P6O7CFW5K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2383555 Internal RxNorm lookup 2383561 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 69794-050-50 DOJOLVI 500 mL in 1 BOTTLE, GLASS LIQUID 500 17 69794-050-50 DOJOLVI 1 in 1 CARTON LIQUID 1 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69794-050 DOJOLVI (TRIHEPTANOIN) LIQUID [ULTRAGENYX PHARMACEUTICAL INC.] 14 Current NDC, Legacy NDC, 2 package rows 20250302_4cfeb8bd-143e-4dd7-bc34-b0bcda02460d.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 Marketing start Marketing end Sample Exclude flag Status 69794-050-50 69794005050 1 BOTTLE, GLASS in 1 CARTON (69794-050-50) / 500 mL in 1 BOTTLE, GLASS 2020-07-01 0000-00-00 No No Current