Home NDC 0169-1709 OZEMPIC
Product NDC 0169-1709
11-digit product format 001691709
Labeler code 0169
Product ID 0169-1709_5176eed4-f8f8-4f88-a079-11f16864f40a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oral semaglutide
Dosage form TABLET
Route ORAL
Labeler Novo Nordisk Pharmaceutical Industries, LP
Application NDA213051
Marketing category NDA
Marketing start 2026-04-27
Substance SEMAGLUTIDE
Active strength 9 mg/1
Pharmacologic classes GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213051-001 RYBELSUS SEMAGLUTIDE 3MG TABLET / ORAL RLD, RS 2019-09-20 N213051-002 RYBELSUS SEMAGLUTIDE 7MG TABLET / ORAL RLD, RS 2019-09-20 N213051-003 RYBELSUS SEMAGLUTIDE 14MG TABLET / ORAL RLD, RS 2019-09-20 N213051-004 OZEMPIC SEMAGLUTIDE 1.5MG TABLET / ORAL RLD, RS 2024-12-09 N213051-005 OZEMPIC SEMAGLUTIDE 4MG TABLET / ORAL RLD, RS 2024-12-09 N213051-006 OZEMPIC SEMAGLUTIDE 9MG TABLET / ORAL RLD, RS 2024-12-09
Orange Book patents# Current patent rows page 1 of 1 · 73 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213051-001 8536122 2026-03-20 U-2628 Drug substance, Drug product 2019-10-15 N213051-001 8129343 2031-12-05 U-2628 Drug substance, Drug product 2019-10-15 N213051-001 10086047 2031-12-16 Drug product 2019-10-15 N213051-001 10960052 2031-12-16 Drug product 2021-04-26 N213051-001 11382957 2031-12-16 Drug product 2022-07-26 N213051-001 9278123 2031-12-16 U-2628 Drug product 2019-10-15 N213051-001 10933120 2033-03-15 Drug product 2021-03-31 N213051-001 11759501 2033-03-15 Drug product 2023-10-12 N213051-001 11759502 2033-03-15 Drug product 2023-10-12 N213051-001 11759503 2033-03-15 Drug product 2023-10-12 N213051-001 12594326 2033-03-15 Drug product 2026-04-20 N213051-001 11033499 2033-06-19 U-2628 Drug product 2026-05-07 N213051-001 10278923 2034-05-02 U-2628 2019-10-15 N213051-001 12239739 2034-05-02 U-2628 Drug substance, Drug product 2025-05-06 N213051-001 12514822 2034-05-02 U-2628 2026-01-14 N213051-002 8536122 2026-03-20 U-2628 Drug substance, Drug product 2019-10-15 N213051-002 8129343 2031-12-05 U-2628 Drug substance, Drug product 2019-10-15 N213051-002 10086047 2031-12-16 Drug product 2019-10-15 N213051-002 10960052 2031-12-16 Drug product 2021-04-26 N213051-002 11382957 2031-12-16 Drug product 2022-07-26 N213051-002 9278123 2031-12-16 U-2628 Drug product 2019-10-15 N213051-002 10933120 2033-03-15 Drug product 2021-03-31 N213051-002 11759501 2033-03-15 Drug product 2023-10-12 N213051-002 11759502 2033-03-15 Drug product 2023-10-12 N213051-002 11759503 2033-03-15 Drug product 2023-10-12 N213051-002 12594326 2033-03-15 Drug product 2026-04-20 N213051-002 11033499 2033-06-19 U-2628 Drug product 2026-05-07 N213051-002 10278923 2034-05-02 U-2628 2019-10-15 N213051-002 12239739 2034-05-02 U-2628 Drug substance, Drug product 2025-05-06 N213051-002 12514822 2034-05-02 U-2628 2026-01-14 N213051-003 8536122 2026-03-20 U-2628 Drug substance, Drug product 2019-10-15 N213051-003 8129343 2031-12-05 U-2628 Drug substance, Drug product 2019-10-15 N213051-003 10086047 2031-12-16 Drug product 2019-10-15 N213051-003 10960052 2031-12-16 Drug product 2021-04-26 N213051-003 11382957 2031-12-16 Drug product 2022-07-26 N213051-003 9278123 2031-12-16 U-2628 Drug product 2019-10-15 N213051-003 10933120 2033-03-15 Drug product 2021-03-31 N213051-003 11759501 2033-03-15 Drug product 2023-10-12 N213051-003 11759502 2033-03-15 Drug product 2023-10-12 N213051-003 11759503 2033-03-15 Drug product 2023-10-12 N213051-003 12594326 2033-03-15 Drug product 2026-04-20 N213051-003 11033499 2033-06-19 U-2628 Drug product 2026-05-07 N213051-003 10278923 2034-05-02 U-2628 2019-10-15 N213051-003 12239739 2034-05-02 U-2628 Drug substance, Drug product 2025-05-06 N213051-003 12514822 2034-05-02 U-2628 2026-01-14 N213051-004 8536122 2026-03-20 U-2628 Drug substance, Drug product 2025-05-06 N213051-004 8129343 2031-12-05 U-2628 Drug substance, Drug product 2025-05-06 N213051-004 11382957 2031-12-16 Drug substance, Drug product 2025-02-21 N213051-004 11033499 2033-06-19 U-2628 Drug product 2026-05-07 N213051-004 10278923 2034-05-02 U-2628 Drug substance, Drug product 2025-02-21 N213051-004 12239739 2034-05-02 U-2628 Drug substance, Drug product 2025-05-06 N213051-004 12514822 2034-05-02 U-2628 2026-01-14 N213051-004 11833248 2039-02-01 U-2628 Drug product 2025-01-07 N213051-004 12396953 2039-02-01 U-2628 Drug product 2025-09-03 N213051-005 8536122 2026-03-20 U-2628 Drug substance, Drug product 2025-05-06 N213051-005 8129343 2031-12-05 U-2628 Drug substance, Drug product 2025-05-06 N213051-005 11382957 2031-12-16 Drug substance, Drug product 2025-02-21 N213051-005 11033499 2033-06-19 U-2628 Drug product 2026-05-07 N213051-005 10278923 2034-05-02 U-2628 Drug substance, Drug product 2025-02-21 N213051-005 12239739 2034-05-02 U-2628 Drug substance, Drug product 2025-05-06 N213051-005 12514822 2034-05-02 U-2628 2026-01-14 N213051-005 11833248 2039-02-01 U-2628 Drug product 2025-01-07 N213051-005 12396953 2039-02-01 U-2628 Drug product 2025-09-03 N213051-006 8536122 2026-03-20 U-2628 Drug substance, Drug product 2025-05-06 N213051-006 8129343 2031-12-05 U-2628 Drug substance, Drug product 2025-05-06 N213051-006 11382957 2031-12-16 Drug substance, Drug product 2025-02-21 N213051-006 9278123 2031-12-16 U-2628 Drug substance, Drug product 2025-02-21 N213051-006 11033499 2033-06-19 U-2628 Drug product 2026-05-07 N213051-006 10278923 2034-05-02 U-2628 Drug substance, Drug product 2025-02-21 N213051-006 12239739 2034-05-02 U-2628 Drug substance, Drug product 2025-05-06 N213051-006 12514822 2034-05-02 U-2628 2026-01-14 N213051-006 11833248 2039-02-01 U-2628 Drug product 2025-01-07 N213051-006 12396953 2039-02-01 U-2628 Drug product 2025-09-03
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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 · 144 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 N213051-001 RYBELSUS 3MG TABLET / ORAL RLD, RS 2019-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 RYBELSUS 7MG TABLET / ORAL RLD, RS 2019-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-003 RYBELSUS 14MG TABLET / ORAL RLD, RS 2019-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-004 OZEMPIC 1.5MG TABLET / ORAL RLD, RS 2024-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-005 OZEMPIC 4MG TABLET / ORAL RLD, RS 2024-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-006 OZEMPIC 9MG TABLET / ORAL RLD, RS 2024-12-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213051-001 RYBELSUS 3MG TABLET / ORAL RLD, RS 2019-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213051-002 RYBELSUS 7MG TABLET / ORAL RLD, RS 2019-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213051-003 RYBELSUS 14MG TABLET / ORAL RLD, RS 2019-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213051-004 RYBELSUS 1.5MG TABLET / ORAL RLD, RS 2024-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213051-005 RYBELSUS 4MG TABLET / ORAL RLD, RS 2024-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213051-006 RYBELSUS 9MG TABLET / ORAL RLD, RS 2024-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213051-001 RYBELSUS 3MG TABLET / ORAL RLD, RS 2019-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213051-002 RYBELSUS 7MG TABLET / ORAL RLD, RS 2019-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213051-003 RYBELSUS 14MG TABLET / ORAL RLD, RS 2019-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213051-004 RYBELSUS 1.5MG TABLET / ORAL RLD, RS 2024-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213051-005 RYBELSUS 4MG TABLET / ORAL RLD, RS 2024-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213051-006 RYBELSUS 9MG TABLET / ORAL RLD, RS 2024-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213051-001 RYBELSUS 3MG TABLET / ORAL RLD, RS 2019-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213051-002 RYBELSUS 7MG TABLET / ORAL RLD, RS 2019-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213051-003 RYBELSUS 14MG TABLET / ORAL RLD, RS 2019-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213051-004 RYBELSUS 1.5MG TABLET / ORAL RLD 2024-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213051-005 RYBELSUS 4MG TABLET / ORAL RLD 2024-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213051-006 RYBELSUS 9MG TABLET / ORAL RLD, RS 2024-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213051-001 RYBELSUS 3MG TABLET / ORAL RLD, RS 2019-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213051-002 RYBELSUS 7MG TABLET / ORAL RLD, RS 2019-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213051-003 RYBELSUS 14MG TABLET / ORAL RLD, RS 2019-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213051-004 RYBELSUS 1.5MG TABLET / ORAL RLD 2024-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213051-005 RYBELSUS 4MG TABLET / ORAL RLD 2024-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213051-006 RYBELSUS 9MG TABLET / ORAL RLD, RS 2024-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213051-001 RYBELSUS 3MG TABLET / ORAL RLD, RS 2019-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213051-002 RYBELSUS 7MG TABLET / ORAL RLD, RS 2019-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213051-003 RYBELSUS 14MG TABLET / ORAL RLD, RS 2019-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213051-004 RYBELSUS 1.5MG TABLET / ORAL RLD 2024-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213051-005 RYBELSUS 4MG TABLET / ORAL RLD 2024-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213051-006 RYBELSUS 9MG TABLET / ORAL RLD, RS 2024-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213051-001 RYBELSUS 3MG TABLET / ORAL RLD, RS 2019-09-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213051-002 RYBELSUS 7MG TABLET / ORAL RLD, RS 2019-09-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213051-003 RYBELSUS 14MG TABLET / ORAL RLD, RS 2019-09-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213051-004 RYBELSUS 1.5MG TABLET / ORAL RLD 2024-12-09 03ed91905a0d…
Observed Orange Book patent history# Patent history page 1 of 32 · 1,254 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 N213051-001 8536122 2026-03-20 U-2628 Drug substance, Drug product 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-001 8129343 2031-12-05 U-2628 Drug substance, Drug product 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-001 10086047 2031-12-16 Drug product 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-001 10960052 2031-12-16 Drug product 2021-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-001 11382957 2031-12-16 Drug product 2022-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-001 9278123 2031-12-16 U-2628 Drug product 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-001 10933120 2033-03-15 Drug product 2021-03-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-001 11759501 2033-03-15 Drug product 2023-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-001 11759502 2033-03-15 Drug product 2023-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-001 11759503 2033-03-15 Drug product 2023-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-001 12594326 2033-03-15 Drug product 2026-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-001 11033499 2033-06-19 U-2628 Drug product 2026-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-001 10278923 2034-05-02 U-2628 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-001 12239739 2034-05-02 U-2628 Drug substance, Drug product 2025-05-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-001 12514822 2034-05-02 U-2628 2026-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 8536122 2026-03-20 U-2628 Drug substance, Drug product 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 8129343 2031-12-05 U-2628 Drug substance, Drug product 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 10086047 2031-12-16 Drug product 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 10960052 2031-12-16 Drug product 2021-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 11382957 2031-12-16 Drug product 2022-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 9278123 2031-12-16 U-2628 Drug product 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 10933120 2033-03-15 Drug product 2021-03-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 11759501 2033-03-15 Drug product 2023-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 11759502 2033-03-15 Drug product 2023-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 11759503 2033-03-15 Drug product 2023-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 12594326 2033-03-15 Drug product 2026-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 11033499 2033-06-19 U-2628 Drug product 2026-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 10278923 2034-05-02 U-2628 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 12239739 2034-05-02 U-2628 Drug substance, Drug product 2025-05-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-002 12514822 2034-05-02 U-2628 2026-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-003 8536122 2026-03-20 U-2628 Drug substance, Drug product 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-003 8129343 2031-12-05 U-2628 Drug substance, Drug product 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-003 10086047 2031-12-16 Drug product 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-003 10960052 2031-12-16 Drug product 2021-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-003 11382957 2031-12-16 Drug product 2022-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-003 9278123 2031-12-16 U-2628 Drug product 2019-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-003 10933120 2033-03-15 Drug product 2021-03-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-003 11759501 2033-03-15 Drug product 2023-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-003 11759502 2033-03-15 Drug product 2023-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213051-003 11759503 2033-03-15 Drug product 2023-10-12 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 180 observed states.
Additional Listing Data#
Finished product Yes
Brand name base OZEMPIC
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SEMAGLUTIDE 9 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 53AXN4NNHX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 15 matching rows.
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 0169-1709-30 OZEMPIC 30 in 1 BOTTLE, PLASTIC TABLET 30 13
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 OZEMPIC ORAL SEMAGLUTIDE Novo Nordisk Pharmaceutical Industries, LP 27f15fac-7d98-4114-a2ec-92494a91da98 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 213051 application number: NDA213051 ndc (product): 0169-1709
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0169-1709-30 00169170930 30 TABLET in 1 BOTTLE, PLASTIC (0169-1709-30) 30 tablet 2026-04-27 No No Current