Home NDC 0003-0213 DAKLINZA
Product NDC 0003-0213
11-digit product format 000030213
Labeler code 0003
Product ID 0003-0213_9581d777-58c4-4b34-afe4-2fa46599426b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name daclatasvir
Dosage form TABLET
Route ORAL
Labeler E.R. Squibb & Sons, L.L.C.
Application NDA206843
Marketing category NDA
Marketing start 2015-07-27
Marketing end 2020-06-30
Substance DACLATASVIR DIHYDROCHLORIDE
Active strength 30 mg/1
Pharmacologic classes Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0003-0213-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0003-0213-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0003-0213-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0003-0213-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0003-0213-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0003-0213-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0003-0213-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0003-0213-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0003-0213-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0003-0213-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0003-0213-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0003-0213-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206843-001 DAKLINZA DACLATASVIR DIHYDROCHLORIDE EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 N206843-002 DAKLINZA DACLATASVIR DIHYDROCHLORIDE EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 N206843-003 DAKLINZA DACLATASVIR DIHYDROCHLORIDE EQ 90MG BASE TABLET / ORAL RLD 2016-04-13
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206843-001 8900566 2027-08-08 U-1724 2015-08-21 N206843-001 8900566 2027-08-08 U-1725 2015-08-21 N206843-001 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 N206843-001 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 N206843-001 8642025 2027-08-11 U-1724 Drug substance, Drug product 2015-08-21 N206843-001 8642025 2027-08-11 U-1725 Drug substance, Drug product 2015-08-21 N206843-001 8329159 2029-07-24 Drug substance 2015-08-21 N206843-001 8629171 2031-06-13 U-1724 Drug substance, Drug product 2015-08-21 N206843-002 8900566 2027-08-08 U-1724 2015-08-21 N206843-002 8900566 2027-08-08 U-1725 2015-08-21 N206843-002 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 N206843-002 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 N206843-002 8642025 2027-08-11 U-1724 Drug substance, Drug product 2015-08-21 N206843-002 8642025 2027-08-11 U-1725 Drug substance, Drug product 2015-08-21 N206843-002 8329159 2029-07-24 Drug substance 2015-08-21 N206843-002 8629171 2031-06-13 U-1724 Drug substance, Drug product 2015-08-21 N206843-003 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 N206843-003 9421192 2027-08-08 U-1725 Drug substance 2016-09-21
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.
Product history page 1 of 4 · 126 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 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206843-002 DAKLINZA EQ 60MG BASE TABLET / ORAL RLD 2015-07-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206843-003 DAKLINZA EQ 90MG BASE TABLET / ORAL RLD 2016-04-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206843-001 DAKLINZA EQ 30MG BASE TABLET / ORAL RLD 2015-07-24 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 19 · 756 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 N206843-001 8900566 2027-08-08 U-1725 2015-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-001 8900566 2027-08-08 U-1724 2015-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-001 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-001 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-001 8642025 2027-08-11 U-1724 Drug substance, Drug product 2015-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-001 8642025 2027-08-11 U-1725 Drug substance, Drug product 2015-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-001 8329159 2029-07-24 Drug substance 2015-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-001 8629171 2031-06-13 U-1724 Drug substance, Drug product 2015-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-002 8900566 2027-08-08 U-1725 2015-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-002 8900566 2027-08-08 U-1724 2015-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-002 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-002 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-002 8642025 2027-08-11 U-1724 Drug substance, Drug product 2015-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-002 8642025 2027-08-11 U-1725 Drug substance, Drug product 2015-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-002 8329159 2029-07-24 Drug substance 2015-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-002 8629171 2031-06-13 U-1724 Drug substance, Drug product 2015-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-003 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206843-003 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206843-001 8900566 2027-08-08 U-1725 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-001 8900566 2027-08-08 U-1724 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-001 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-001 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-001 8642025 2027-08-11 U-1724 Drug substance, Drug product 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-001 8642025 2027-08-11 U-1725 Drug substance, Drug product 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-001 8329159 2029-07-24 Drug substance 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-001 8629171 2031-06-13 U-1724 Drug substance, Drug product 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 8900566 2027-08-08 U-1725 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 8900566 2027-08-08 U-1724 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 8642025 2027-08-11 U-1724 Drug substance, Drug product 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 8642025 2027-08-11 U-1725 Drug substance, Drug product 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 8329159 2029-07-24 Drug substance 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-002 8629171 2031-06-13 U-1724 Drug substance, Drug product 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-003 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206843-003 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-001 8900566 2027-08-08 U-1725 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-001 8900566 2027-08-08 U-1724 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-001 9421192 2027-08-08 U-1725 Drug substance 2016-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206843-001 9421192 2027-08-08 U-1724 Drug substance 2016-09-21 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 44 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DACLATASVIR DIHYDROCHLORIDE ACTIVE INGREDIENT 50ZO25C11D DAKLINZA (DACLATASVIR) TABLET [E.R. SQUIBB & SONS, L.L.C.] 2 DACLATASVIR ACTIVE MOIETY LI2427F9CI DAKLINZA (DACLATASVIR) TABLET [E.R. SQUIBB & SONS, L.L.C.] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 DAKLINZA (DACLATASVIR) TABLET [E.R. SQUIBB & SONS, L.L.C.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DAKLINZA (DACLATASVIR) TABLET [E.R. SQUIBB & SONS, L.L.C.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DAKLINZA (DACLATASVIR) TABLET [E.R. SQUIBB & SONS, L.L.C.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DAKLINZA (DACLATASVIR) TABLET [E.R. SQUIBB & SONS, L.L.C.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DAKLINZA (DACLATASVIR) TABLET [E.R. SQUIBB & SONS, L.L.C.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DAKLINZA (DACLATASVIR) TABLET [E.R. SQUIBB & SONS, L.L.C.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DAKLINZA (DACLATASVIR) TABLET [E.R. SQUIBB & SONS, L.L.C.] 2 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L DAKLINZA (DACLATASVIR) TABLET [E.R. SQUIBB & SONS, L.L.C.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DAKLINZA (DACLATASVIR) TABLET [E.R. SQUIBB & SONS, L.L.C.] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ DAKLINZA (DACLATASVIR) TABLET [E.R. SQUIBB & SONS, L.L.C.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DAKLINZA (DACLATASVIR) TABLET [E.R. SQUIBB & SONS, L.L.C.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DAKLINZA (DACLATASVIR) TABLET [E.R. SQUIBB & SONS, L.L.C.] 2