Application 018878

Type: NDA
Sponsor: RECORDATI RARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INDOCIN	INDOMETHACIN SODIUM	INJECTABLE;INJECTION	EQ 1MG BASE/VIAL	Yes	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
N018878-001	INDOCIN	INDOMETHACIN SODIUM	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30

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UTC	2026-02	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018878-001	INDOCIN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1985-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018878-001	INDOCIN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1985-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018878-001	INDOCIN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1985-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018878-001	INDOCIN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018878-001	INDOCIN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1985-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018878-001	INDOCIN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1985-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018878-001	INDOCIN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1985-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018878-001	INDOCIN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1985-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018878-001	INDOCIN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1985-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018878-001	INDOCIN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018878-001	INDOCIN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018878-001	INDOCIN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018878-001	INDOCIN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018878-001	INDOCIN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1985-01-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018878-001	INDOCIN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1985-01-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N018878-001	AP	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	N018878-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018878-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018878-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018878-001	AP	1	`ea99ee380514…`

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
INDOCIN	INDOMETHACIN	Zyla Life Sciences US Inc.	3b36645c-de5e-4263-ae06-2f6ff6a9add2	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: INDOCIN
Indocin	INDOMETHACIN	Zyla Life Sciences US LLC	73878376-1d24-423b-9f37-3666e83c95da	2024-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indocin

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66913	SUPPL	2021-03-30
66901	SUPPL	2021-03-29
16078	SUPPL	2010-01-26
33630	SUPPL	2010-01-20
1113	SUPPL	2007-01-25
11355	SUPPL	2007-01-16
16077	SUPPL	2006-02-08
33629	SUPPL	2006-02-07
16076	SUPPL	2003-05-30
1112	SUPPL	2003-05-30