Home NDC 42667-5511 Natesto
Product NDC 42667-5511
11-digit product format 426675511
Labeler code 42667
Product ID 42667-5511_3ab4a3a7-6d2d-ac70-e063-6394a90afb84
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name testosterone
Dosage form GEL, METERED
Route NASAL
Labeler Acerus Pharmaceuticals Corporation
Application NDA205488
Marketing category NDA
Marketing start 2020-05-08
Substance TESTOSTERONE
Active strength 5.5 mg/.122g
Pharmacologic classes Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205488-001 NATESTO TESTOSTERONE 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205488-001 11090312 2034-03-17 U-1616 2021-09-10 N205488-001 11744838 2034-03-17 U-4366 2026-01-07 N205488-001 11744838 2034-03-17 U-4367 2026-01-07
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 · 42 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 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL RLD, RS 2014-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205488-001 NATESTO 5.5MG/0.122GM ACTUATION GEL, METERED / NASAL 2014-05-28 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 5 · 180 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 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205488-001 11744838 2034-03-17 U-4366 2026-01-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205488-001 11744838 2034-03-17 U-4367 2026-01-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205488-001 11744838 2034-03-17 U-4366 2026-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205488-001 11744838 2034-03-17 U-4367 2026-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205488-001 8574622 2024-02-04 Drug product 2014-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205488-001 8784869 2024-02-04 Drug product 2014-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205488-001 8784882 2024-02-04 U-1557 Drug product 2014-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205488-001 8877230 2024-02-04 U-1616 2014-12-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205488-001 8574622 2024-02-04 Drug product 2014-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205488-001 8784869 2024-02-04 Drug product 2014-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205488-001 8784882 2024-02-04 U-1557 Drug product 2014-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205488-001 8877230 2024-02-04 U-1616 2014-12-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205488-001 8574622 2024-02-04 Drug product 2014-06-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205488-001 8784869 2024-02-04 Drug product 2014-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205488-001 8784882 2024-02-04 U-1557 Drug product 2014-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205488-001 8877230 2024-02-04 U-1616 2014-12-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205488-001 8574622 2024-02-04 Drug product 2014-06-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205488-001 8784869 2024-02-04 Drug product 2014-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205488-001 8784882 2024-02-04 U-1557 Drug product 2014-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205488-001 8877230 2024-02-04 U-1616 2014-12-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205488-001 8574622 2024-02-04 Drug product 2014-06-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205488-001 8784869 2024-02-04 Drug product 2014-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205488-001 8784882 2024-02-04 U-1557 Drug product 2014-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205488-001 8877230 2024-02-04 U-1616 2014-12-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205488-001 8574622 2024-02-04 Drug product 2014-06-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205488-001 8784869 2024-02-04 Drug product 2014-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205488-001 8784882 2024-02-04 U-1557 Drug product 2014-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205488-001 8877230 2024-02-04 U-1616 2014-12-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205488-001 11090312 2034-03-17 U-1616 2021-09-10 79d66fd596c7…
Additional Listing Data#
Finished product Yes
Brand name base Natesto
Brand name suffix nasal gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TESTOSTERONE 5.5 mg/.122g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3XMK78S47O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1596782 Internal RxNorm lookup 1596784 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 42667-5511-1 Natestonasal gel 1 in 1 BOX GEL, METERED 1 18 42667-5511-1 Natestonasal gel 11 g in 1 APPLICATOR GEL, METERED 11 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42667-5511 NATESTO NASAL GEL (TESTOSTERONE) GEL, METERED [ACERUS PHARMACEUTICALS CORPORATION] 17 Current NDC, Legacy NDC, 2 package rows 20250403_dea6bed1-eaca-11e3-ac10-0800200c9a66.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 42667-5511-1 42667551101 1 APPLICATOR in 1 BOX (42667-5511-1) / 11 g in 1 APPLICATOR 1 applicator 2020-05-08 0000-00-00 No No Current