Home NDC 0069-1975 Vyndaqel
Product NDC 0069-1975
11-digit product format 000691975
Labeler code 0069
Product ID 0069-1975_67f1031d-c298-4cf9-9051-bb8f99e56442
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tafamidis meglumine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA211996
Marketing category NDA
Marketing start 2019-05-16
Marketing end 2027-07-31
Substance TAFAMIDIS MEGLUMINE
Active strength 20 mg/1
NDC exclude flag No
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 N211996-001 VYNDAQEL TAFAMIDIS MEGLUMINE 20MG CAPSULE / ORAL RLD 2019-05-03
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 N211996-001 7214695 2026-12-19 Drug substance, Drug product 2019-05-30 N211996-001 7214696 2026-12-19 U-2524 2019-05-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211996-001 ODE-237 2026-05-03
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 · 43 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 2026-09-14 22:38:34 2026-08 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD 2019-05-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD 2019-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD 2019-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211996-001 VYNDAQEL 20MG CAPSULE / ORAL RLD, RS 2019-05-03 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 4 · 134 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 N211996-001 7214695 2026-12-19 Drug substance, Drug product 2019-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211996-001 7214696 2026-12-19 U-2524 2019-05-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211996-001 7214695 2026-12-19 Drug substance, Drug product 2019-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211996-001 7214696 2026-12-19 U-2524 2019-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211996-001 7214695 2026-12-19 Drug substance, Drug product 2019-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211996-001 7214696 2026-12-19 U-2524 2019-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211996-001 7214695 2026-12-19 Drug substance, Drug product 2019-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211996-001 7214696 2026-12-19 U-2524 2019-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211996-001 7214695 2025-12-19 Drug substance, Drug product 2019-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211996-001 7214696 2025-12-19 U-2524 2019-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211996-001 7214695 2025-12-19 Drug substance, Drug product 2019-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211996-001 7214696 2025-12-19 U-2524 2019-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211996-001 7214695 2025-12-19 Drug substance, Drug product 2019-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211996-001 7214696 2025-12-19 U-2524 2019-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211996-001 7214695 2025-12-19 Drug substance, Drug product 2019-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211996-001 7214696 2025-12-19 U-2524 2019-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211996-001 7214695 2025-12-19 Drug substance, Drug product 2019-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211996-001 7214696 2025-12-19 U-2524 2019-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211996-001 7214695 2024-12-19 Drug substance, Drug product 2019-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211996-001 7214696 2024-12-19 U-2524 2019-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211996-001 7214695 2025-12-19 Drug substance, Drug product 2019-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211996-001 7214696 2025-12-19 U-2524 2019-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211996-001 7214695 2025-12-19 Drug substance, Drug product 2019-05-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211996-001 7214696 2025-12-19 U-2524 2019-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211996-001 7214695 2024-12-19 Drug substance, Drug product 2019-05-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211996-001 7214696 2024-12-19 U-2524 2019-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211996-001 7214695 2024-12-19 Drug substance, Drug product 2019-05-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211996-001 7214696 2024-12-19 U-2524 2019-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211996-001 7214695 2024-12-19 Drug substance, Drug product 2019-05-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211996-001 7214696 2024-12-19 U-2524 2019-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211996-001 7214695 2024-12-19 Drug substance, Drug product 2019-05-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211996-001 7214696 2024-12-19 U-2524 2019-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211996-001 7214696 2023-12-19 U-2524 2019-05-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211996-001 8168663 2023-12-19 Drug substance, Drug product 2019-05-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211996-001 8653119 2024-01-28 U-2524 2019-05-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211996-001 7214695 2024-04-27 Drug substance, Drug product 2019-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211996-001 7214696 2023-12-19 U-2524 2019-05-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211996-001 8168663 2023-12-19 Drug substance, Drug product 2019-05-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211996-001 8653119 2024-01-28 U-2524 2019-05-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211996-001 7214695 2024-04-27 Drug substance, Drug product 2019-05-30 5d02ea3f76ae…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 78 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 Vyndaqel Active Ingredients# Ingredient, Strength table Ingredient Strength TAFAMIDIS MEGLUMINE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZU7CF08A1A Internal UNII lookup 8FG9H9D31J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2168534 Internal RxNorm lookup 2168540 Internal RxNorm lookup 2168542 Internal RxNorm lookup 2168548 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 0069-1975-12 Vyndaqel 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 15 0069-1975-40 Vyndaqel 30 in 1 CARTON CAPSULE, LIQUID FILLED 30 15 0069-1975-40 Vyndaqel 4 in 1 CARTON CAPSULE, LIQUID FILLED 4 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-1975 VYNDAQEL (TAFAMIDIS MEGLUMINE) CAPSULE, LIQUID FILLED VYNDAMAX (TAFAMIDIS) CAPSULE, LIQUID FILLED [PFIZER LABORATORIES DIV PFIZER INC] 13 Current NDC, Legacy NDC, 3 package rows 20250103_1b4121ee-a733-4456-a917-be2603477839.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 Marketing end Sample Exclude flag Status 0069-1975-12 00069197512 1 in 1 BLISTER PACK Historical 0069-1975-40 00069197540 4 CARTON in 1 CARTON (0069-1975-40) / 30 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0069-1975-12) 4 carton 2019-05-16 2027-07-31 No No Current