Mycapssa

Product NDC: 10122-550
11-digit product format: 101220550
Labeler code: 10122
Product ID: 10122-550_84ca5e5f-886b-4216-b748-f7dad1201db0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Octreotide
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Chiesi USA, Inc.
Application: NDA208232
Marketing category: NDA
Marketing start: 2020-07-06
Substance: OCTREOTIDE
Active strength: 20 mg/1
Pharmacologic classes: Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
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
N208232-001	MYCAPSSA	OCTREOTIDE ACETATE	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2020-06-26

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208232-001	11969471	2029-09-17		Drug product	2024-04-30
N208232-001	11986529	2029-09-17	U-2857		2024-06-14
N208232-001	8329198	2029-09-17		Drug product	2020-07-23
N208232-001	8535695	2029-09-17	U-2857		2020-07-23
N208232-001	9265812	2029-09-17		Drug product	2020-07-23
N208232-001	9566246	2029-09-17		Drug product	2020-07-23
N208232-001	10238709	2036-02-03	U-2857		2020-07-23
N208232-001	10695397	2036-02-03	U-2857		2020-07-23
N208232-001	11052126	2036-02-03	U-2857		2021-07-22
N208232-001	11338011	2036-02-03	U-2857		2022-06-22
N208232-001	11510963	2036-02-03	U-2857		2022-12-19
N208232-001	11857595	2036-02-03	U-3784		2024-01-31
N208232-001	12246054	2036-02-03	U-2857		2025-04-03
N208232-001	12251418	2036-02-03	U-2857		2025-04-03
N208232-001	11141457	2040-12-28	U-3232		2021-11-04
N208232-001	11890316	2040-12-28	U-3232		2024-03-05

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208232-001	ODE-474	2027-06-26

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208232-001	MYCAPSSA	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2020-06-26	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 425 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	N208232-001	11969471	2029-09-17		Drug product	2024-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	11986529	2029-09-17	U-2857		2024-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	8329198	2029-09-17		Drug product	2020-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	8535695	2029-09-17	U-2857		2020-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	9265812	2029-09-17		Drug product	2020-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	9566246	2029-09-17		Drug product	2020-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	10238709	2036-02-03	U-2857		2020-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	10695397	2036-02-03	U-2857		2020-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	11052126	2036-02-03	U-2857		2021-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	11338011	2036-02-03	U-2857		2022-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	11510963	2036-02-03	U-2857		2022-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	11857595	2036-02-03	U-3784		2024-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	12246054	2036-02-03	U-2857		2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	12251418	2036-02-03	U-2857		2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	11141457	2040-12-28	U-3232		2021-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208232-001	11890316	2040-12-28	U-3232		2024-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208232-001	11969471	2029-09-17		Drug product	2024-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	11986529	2029-09-17	U-2857		2024-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	8329198	2029-09-17		Drug product	2020-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	8535695	2029-09-17	U-2857		2020-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	9265812	2029-09-17		Drug product	2020-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	9566246	2029-09-17		Drug product	2020-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	10238709	2036-02-03	U-2857		2020-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	10695397	2036-02-03	U-2857		2020-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	11052126	2036-02-03	U-2857		2021-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	11338011	2036-02-03	U-2857		2022-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	11510963	2036-02-03	U-2857		2022-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	11857595	2036-02-03	U-3784		2024-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	12246054	2036-02-03	U-2857		2025-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	12251418	2036-02-03	U-2857		2025-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	11141457	2040-12-28	U-3232		2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208232-001	11890316	2040-12-28	U-3232		2024-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208232-001	11969471	2029-09-17		Drug product	2024-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208232-001	11986529	2029-09-17	U-2857		2024-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208232-001	8329198	2029-09-17		Drug product	2020-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208232-001	8535695	2029-09-17	U-2857		2020-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208232-001	9265812	2029-09-17		Drug product	2020-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208232-001	9566246	2029-09-17		Drug product	2020-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208232-001	10238709	2036-02-03	U-2857		2020-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208232-001	10695397	2036-02-03	U-2857		2020-07-23	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N208232-001	ODE-474	2027-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208232-001	ODE-474	2027-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208232-001	ODE-474	2027-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208232-001	ODE-474	2027-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208232-001	ODE-474	2027-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208232-001	ODE-474	2027-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208232-001	ODE-474	2027-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208232-001	ODE-474	2027-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208232-001	ODE-474	2027-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208232-001	ODE-474	2027-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208232-001	ODE-474	2027-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208232-001	ODE-474	2027-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208232-001	ODE-474	2027-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208232-001	ODE-474	2027-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208232-001	ODE-474	2027-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208232-001	NP	2023-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208232-001	NP	2023-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208232-001	NP	2023-06-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208232-001	NP	2023-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208232-001	NP	2023-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208232-001	NP	2023-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208232-001	NP	2023-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208232-001	NP	2023-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208232-001	NP	2023-06-26	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N208232-001	NP	2023-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208232-001	NP	2023-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208232-001	NP	2023-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208232-001	NP	2023-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208232-001	NP	2023-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208232-001	NP	2023-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208232-001	NP	2023-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208232-001	NP	2023-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208232-001	NP	2023-06-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208232-001	NP	2023-06-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208232-001	NP	2023-06-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208232-001	ODE-474	2027-06-26	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mycapssa
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTREOTIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RWM8CCW8GP	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2380611	Internal RxNorm lookup
2380617	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
58d80bc6-bdfb-4908-93e7-aace447c8d1a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
813db1d8-6534-4d2d-be9e-8d2c20a55eda	Product name	1	20241217
a6ddfef5-d553-2919-73fa-8aede2a8ab27	Product name	5	20240823
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
8f3fde6c-976e-4e4c-8ed4-542294fcc0ef	Product name	1	20210115
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
467fba3a-c020-419e-8102-aeb9c0ea15ec	Product name	1	20200616
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10122-550-28	Mycapssa	7 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	7		6
10122-550-28	Mycapssa	4 in 1 DOSE PACK	CAPSULE, DELAYED RELEASE	4		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10122-550-28	EA - Each	10122-550	7872f30e-6fff-459d-9e8b-231c1212a130	1	2026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10122-550	MYCAPSSA (OCTREOTIDE) CAPSULE, DELAYED RELEASE [CHIESI USA, INC.]	5	Current NDC, 2 package rows	20240824_58d80bc6-bdfb-4908-93e7-aace447c8d1a.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mycapssa	OCTREOTIDE	Amryt Pharmaceuticals Designated Activity Company	62a5e1eb-b48e-4ea6-8781-f75e490b17e4	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208232 application number: NDA208232
Mycapssa	OCTREOTIDE	Chiesi USA, Inc.	58d80bc6-bdfb-4908-93e7-aace447c8d1a	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208232 application number: NDA208232 ndc (product): 10122-550

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RWM8CCW8GP	OCTREOTIDE	83150-76-9	OCTREOTIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2380617	Mycapssa 20 MG Delayed Release Oral Capsule	PSN	58d80bc6-bdfb-4908-93e7-aace447c8d1a	6
2380611	octreotide 20 MG Delayed Release Oral Capsule	PSN	58d80bc6-bdfb-4908-93e7-aace447c8d1a	6
2380617	octreotide 20 MG Delayed Release Oral Capsule [Mycapssa]	SBD	58d80bc6-bdfb-4908-93e7-aace447c8d1a	6
2380611	octreotide 20 MG Delayed Release Oral Capsule	SCD	58d80bc6-bdfb-4908-93e7-aace447c8d1a	6
2380617	Mycapssa 20 MG Delayed Release Oral Capsule	SY	58d80bc6-bdfb-4908-93e7-aace447c8d1a	6
2380611	octreotide (as octreotide acetate) 20 MG Delayed Release Oral Capsule	SY	58d80bc6-bdfb-4908-93e7-aace447c8d1a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10122-550-28	10122055028	4 BLISTER PACK in 1 DOSE PACK (10122-550-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	4 blister pack	2020-07-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mycapssa	Chiesi USA, Inc. \| Almac Pharma Services Limited \| Assia Chemical Industries Ltd. - Teva Tech Site \| Lyophilization Services of New England, Inc. (LSNE) \| MW ENCAP LIMITED \| Novetide Ltd.	2025-07-24	HUMAN PRESCRIPTION DRUG LABEL	6