Home NDC 67979-511 Aveed
Product NDC 67979-511
11-digit product format 679790511
Labeler code 67979
Product ID 67979-511_da249940-81ef-4af3-8c59-4697e0404e71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name testosterone undecanoate
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Endo USA, Inc.
Application NDA022219
Marketing category NDA
Marketing start 2014-03-05
Substance TESTOSTERONE UNDECANOATE
Active strength 250 mg/mL
Pharmacologic classes Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule CIII
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 1 .
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 N022219-001 AVEED TESTOSTERONE UNDECANOATE 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05
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 N022219-001 7718640 2027-03-14 Drug product N022219-001 8338395 2027-05-08 U-1500
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022219-001 AVEED 750MG/3ML (250MG/ML) INJECTABLE / INTRAMUSCULAR RLD, RS 2014-03-05 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022219-001 7718640 2027-03-14 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022219-001 8338395 2027-05-08 U-1500 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022219-001 7718640 2027-03-14 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022219-001 8338395 2027-05-08 U-1500 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022219-001 7718640 2027-03-14 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022219-001 8338395 2027-05-08 U-1500 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022219-001 7718640 2027-03-14 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022219-001 8338395 2027-05-08 U-1500 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022219-001 7718640 2027-03-14 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022219-001 8338395 2027-05-08 U-1500 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022219-001 7718640 2027-03-14 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022219-001 8338395 2027-05-08 U-1500 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022219-001 7718640 2027-03-14 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022219-001 8338395 2027-05-08 U-1500 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022219-001 7718640 2027-03-14 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022219-001 8338395 2027-05-08 U-1500 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022219-001 7718640 2027-03-14 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022219-001 8338395 2027-05-08 U-1500 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022219-001 7718640 2027-03-14 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022219-001 8338395 2027-05-08 U-1500 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022219-001 7718640 2027-03-14 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022219-001 8338395 2027-05-08 U-1500 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022219-001 7718640 2027-03-14 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022219-001 8338395 2027-05-08 U-1500 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022219-001 7718640 2027-03-14 Drug product 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022219-001 8338395 2027-05-08 U-1500 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022219-001 7718640 2027-03-14 Drug product 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022219-001 8338395 2027-05-08 U-1500 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022219-001 7718640 2027-03-14 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022219-001 8338395 2027-05-08 U-1500 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022219-001 7718640 2027-03-14 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022219-001 8338395 2027-05-08 U-1500 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022219-001 7718640 2027-03-14 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022219-001 8338395 2027-05-08 U-1500 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022219-001 8338395 2026-02-27 U-1500 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022219-001 7718640 2027-03-14 Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022219-001 7718640 2027-03-14 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022219-001 8338395 2027-05-08 U-1500 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022219-001 7718640 2027-03-14 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022219-001 8338395 2027-05-08 U-1500 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Aveed
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TESTOSTERONE UNDECANOATE 250 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H16A5VCT9C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1490661 Internal RxNorm lookup 1490667 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 67979-511-43 Aveed 3 mL in 1 VIAL, SINGLE-USE INJECTION 3 45 67979-511-43 Aveed 1 in 1 CARTON INJECTION 1 45
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67979-511 AVEED (TESTOSTERONE UNDECANOATE) INJECTION [ENDO USA, INC.] 43 Current NDC, Legacy NDC, 2 package rows 20240425_f80f025b-17d8-40af-8739-20ce07902045.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 Aveed TESTOSTERONE UNDECANOATE Endo USA, Inc. f80f025b-17d8-40af-8739-20ce07902045 2025-07-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022219 application number: NDA022219 ndc (product): 67979-511
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 67979-511-43 67979051143 1 VIAL, SINGLE-USE in 1 CARTON (67979-511-43) / 3 mL in 1 VIAL, SINGLE-USE 2014-03-05 0000-00-00 No No Current