52483-0014-0

Product NDC: 52483-0014
Requested package NDC: 52483-0014-0
11-digit product format: 524830014
Labeler code: 52483
Product ID: 52483-0014_4b3d81c5-dc8f-4b28-8a6e-8596dad3e759
Type: DRUG FOR FURTHER PROCESSING
Nonproprietary name: entacapone
Dosage form: TABLET, FILM COATED
Marketing category: DRUG FOR FURTHER PROCESSING
Marketing start: 2014-03-24
Substance: ENTACAPONE
Active strength: 200 mg/1
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	52483-0014	52483-0014-0	UNFINISHED	Active or certified unfinished drug listing		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: No
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ENTACAPONE	200 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ce6fab2-d006-4589-8ba0-02cee499cc60	Product name	2	20260128
6a098371-84f5-7ced-0ac5-ed90d535b476	Product name	6	20220927

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ENTACAPONE	ACTIVE INGREDIENT	4975G9NM6T	ENTACAPONE TABLET, FILM COATED [SANDOZ INC]	10
ENTACAPONE	ACTIVE MOIETY	4975G9NM6T	ENTACAPONE TABLET, FILM COATED [SANDOZ INC]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ENTACAPONE TABLET, FILM COATED [SANDOZ INC]	10
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ENTACAPONE TABLET, FILM COATED [SANDOZ INC]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ENTACAPONE TABLET, FILM COATED [SANDOZ INC]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ENTACAPONE TABLET, FILM COATED [SANDOZ INC]	10
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ENTACAPONE TABLET, FILM COATED [SANDOZ INC]	10
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	ENTACAPONE TABLET, FILM COATED [SANDOZ INC]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ENTACAPONE TABLET, FILM COATED [SANDOZ INC]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ENTACAPONE TABLET, FILM COATED [SANDOZ INC]	10
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ENTACAPONE TABLET, FILM COATED [SANDOZ INC]	10
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ENTACAPONE TABLET, FILM COATED [SANDOZ INC]	10
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ENTACAPONE TABLET, FILM COATED [SANDOZ INC]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ENTACAPONE TABLET, FILM COATED [SANDOZ INC]	10

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4975G9NM6T	ENTACAPONE	130929-57-6	ENTACAPONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
317094	entacapone 200 MG Oral Tablet	PSN	ad4b6d79-efd3-4c43-b4dc-5afdacf939a4	14
317094	entacapone 200 MG Oral Tablet	SCD	ad4b6d79-efd3-4c43-b4dc-5afdacf939a4	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
52483-0014-0	52483001400	1 BAG in 1 DRUM (52483-0014-0) / 62000 TABLET, FILM COATED in 1 BAG	1 bag	24-MAR-14	Current