Home NDC 0169-1401 Macrilen
Product NDC 0169-1401
11-digit product format 001691401
Labeler code 0169
Product ID 0169-1401_ed003972-d498-43fc-b809-05a47d86b8da
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Macimorelin acetate
Dosage form GRANULE, FOR SOLUTION
Route ORAL
Labeler Novo Nordisk
Application NDA205598
Marketing category NDA
Marketing start 2022-01-31
Marketing end 2027-02-28
Substance MACIMORELIN
Active strength 60 mg/mg
Pharmacologic classes Growth Hormone Secretagogue Receptor Agonist [EPC], Growth Hormone Secretagogue Receptor Agonists [MoA]
NDC exclude flag No
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 N205598-001 MACRILEN MACIMORELIN ACETATE EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20
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 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 N205598-001 8192719*PED 2028-04-12 Pediatric extension
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 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD 2017-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205598-001 MACRILEN EQ 60MG BASE/POUCH FOR SOLUTION / ORAL RLD, RS 2017-12-20 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 2 · 62 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 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205598-001 8192719*PED 2028-04-12 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205598-001 6861409 2022-08-01 U-2220 Drug substance, Drug product 2018-01-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205598-001 6861409 2022-08-01 U-2220 Drug substance, Drug product 2018-01-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205598-001 6861409 2022-08-01 U-2220 Drug substance, Drug product 2018-01-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205598-001 6861409 2022-08-01 U-2220 Drug substance, Drug product 2018-01-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205598-001 6861409 2022-08-01 U-2220 Drug substance, Drug product 2018-01-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205598-001 6861409 2022-08-01 U-2220 Drug substance, Drug product 2018-01-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205598-001 6861409 2022-08-01 U-2220 Drug substance, Drug product 2018-01-19 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205598-001 6861409 2022-08-01 U-2220 Drug substance, Drug product 2018-01-19 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205598-001 6861409 2022-08-01 U-2220 Drug substance, Drug product 2018-01-19 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205598-001 6861409 2022-08-01 U-2220 Drug substance, Drug product 2018-01-19 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205598-001 6861409 2022-08-01 U-2220 Drug substance, Drug product 2018-01-19 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205598-001 6861409 2022-08-01 U-2220 Drug substance, Drug product 2018-01-19 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N205598-001 8192719 2027-10-12 U-2220 2018-01-19 b00525d2431f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 53 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Macrilen Active Ingredients# Ingredient, Strength table Ingredient Strength MACIMORELIN 60 mg/mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8680B21W73 Internal UNII 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 0169-1401-01 Macrilen 1 in 1 CARTON GRANULE, FOR SOLUTION 1 7 0169-1401-01 Macrilen 60 mg in 1 POUCH GRANULE, FOR SOLUTION 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0169-1401 MACRILEN (MACIMORELIN ACETATE) GRANULE, FOR SOLUTION [NOVO NORDISK] 6 Current NDC, Legacy NDC, 2 package rows 20241220_6034c9b8-5a36-4961-a5dd-11ebf7bdab78.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0169-1401-01 00169140101 1 POUCH in 1 CARTON (0169-1401-01) / 60 mg in 1 POUCH 1 pouch 2022-01-31 2027-02-28 No No Current