Home NDC 0310-9400 WAINUA
Product NDC 0310-9400
11-digit product format 003109400
Labeler code 0310
Product ID 0310-9400_cea076d0-c827-4c46-9b36-418bf63d5a9d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name EPLONTERSEN
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler AstraZeneca Pharmaceuticals LP
Application NDA217388
Marketing category NDA
Marketing start 2023-12-21
Substance EPLONTERSEN
Active strength 45 mg/.8mL
Pharmacologic classes Antisense Oligonucleotide [EPC], Decreased RNA Integrity [PE], Increased Protein Breakdown [PE], Oligonucleotides, Antisense [CS], Transthyretin-directed RNA Interaction [EPC]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217388-001 WAINUA (AUTOINJECTOR) EPLONTERSEN SODIUM EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 N217388-002 WAINUA EPLONTERSEN SODIUM EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2026-04-15
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217388-001 8101743 2026-04-01 Drug substance, Drug product 2024-01-18 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 N217388-002 9127276 2034-05-01 Drug substance 2026-06-12 N217388-002 9181549 2034-05-01 Drug substance 2026-06-12 N217388-002 10683499 2034-08-25 U-2378 Drug substance, Drug product 2026-06-12
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217388-001 NCE 2028-12-21 N217388-001 ODE-461 2030-12-21
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.
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 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217388-002 WAINUA EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2026-04-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217388-002 WAINUA EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2026-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217388-001 WAINUA EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217388-001 WAINUA (AUTOINJECTOR) EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2023-12-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217388-002 WAINUA EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) SOLUTION / SUBCUTANEOUS RLD, RS 2026-04-15 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 85 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 N217388-001 8101743 2026-04-01 Drug substance, Drug product 2024-01-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217388-002 9127276 2034-05-01 Drug substance 2026-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217388-002 9181549 2034-05-01 Drug substance 2026-06-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217388-002 10683499 2034-08-25 U-2378 Drug substance, Drug product 2026-06-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217388-001 8101743 2026-04-01 Drug substance, Drug product 2024-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217388-002 9127276 2034-05-01 Drug substance 2026-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217388-002 9181549 2034-05-01 Drug substance 2026-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217388-002 10683499 2034-08-25 U-2378 Drug substance, Drug product 2026-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217388-001 8101743 2026-04-01 Drug substance, Drug product 2024-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217388-001 8101743 2026-04-01 Drug substance, Drug product 2024-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217388-001 8101743 2026-04-01 Drug substance, Drug product 2024-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217388-001 8101743 2025-04-01 Drug substance, Drug product 2024-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217388-001 8101743 2025-04-01 Drug substance, Drug product 2024-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217388-001 8101743 2025-04-01 Drug substance, Drug product 2024-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217388-001 9181549 2034-05-01 Drug substance 2024-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217388-001 10683499 2034-08-25 U-2378 Drug substance, Drug product 2024-01-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217388-001 8101743 2025-04-01 Drug substance, Drug product 2024-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217388-001 9127276 2034-05-01 Drug substance 2024-01-18 2680178bc6a6…
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 WAINUA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPLONTERSEN 45 mg/.8mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0GRZ0F5XJ6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2671944 Internal RxNorm lookup 2671950 Internal RxNorm lookup 2741485 Internal RxNorm lookup 2741488 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 0310-9400-01 WAINUA 1 in 1 CARTON INJECTION, SOLUTION 1 20 0310-9400-01 WAINUA 0.8 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 0.8 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-9400 WAINUA (EPLONTERSEN) INJECTION, SOLUTION [ASTRAZENECA PHARMACEUTICALS LP] 9 Current NDC, 2 package rows 20250425_d7dcb847-71dd-4fff-82d0-d43a465fc096.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 WAINUA EPLONTERSEN AstraZeneca Pharmaceuticals LP d7dcb847-71dd-4fff-82d0-d43a465fc096 2026-04-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 217388 application number: NDA217388 ndc (product): 0310-9400
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0310-9400-01 00310940001 1 SYRINGE, GLASS in 1 CARTON (0310-9400-01) / .8 mL in 1 SYRINGE, GLASS 2023-12-21 No No Current