NDC 89141-448-01 - ZUPLENZ

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 89141-448
Requested NDC: 89141-448-01
Package NDCs from labels: 89141-448-01, 89141-448-30
Manufacturer: Fortovia Therapeutics, Inc. | Aquestive Therapeutics
Effective date: 2021-10-20
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ZUPLENZ - Fortovia Therapeutics, Inc. \| Aquestive Therapeutics	Fortovia Therapeutics, Inc. \| Aquestive Therapeutics	2021-10-20	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
89141-448-30	2021-10-20	C162847	48780-1	c7ccaba7-1b6f-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use ZUPLENZ ® safely and effectively. See full prescribing information for ZUPLENZ. ZUPLENZ (ondansetron) Oral Soluble Film Initial U.S. Approval: 1991
89141-448-30	2021-07-23	C162847	48780-1	c7ccaba7-1b6f-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use ZUPLENZ ® safely and effectively. See full prescribing information for ZUPLENZ. ZUPLENZ (ondansetron) Oral Soluble Film Initial U.S. Approval: 1991

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
89141-448-01	EA - Each	89141-448	09ade7b6-cf8e-4924-8025-0249f10b166c	1	2017-03-06
89141-448-30	EA - Each	89141-448	660d5a2e-8c15-4464-bbd0-bcf024ebf392	1	2017-03-06

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 84 of 176 · 3,517 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole and sodium bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	H E B	ddc8d73f-f4a1-42a7-89ee-420346820f61	2025-11-03	Warnings	Exact identifier unii: 8MDF5V39QO
Ondansetron	ONDANSETRON	Proficient Rx LP	81366c85-c6c9-4a9a-9fe5-cdd8c2d19f74	2025-11-01	Warnings, Adverse reactions	Exact identifier unii: 4AF302ESOS
e l f Camo Semi Matte CC SPF 30 Light 205 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	055878ef-c671-4d65-9639-bda5a1dc3029	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Fair 120 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	b6b18a13-1f22-4061-91f5-852f7a487c03	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Fair 100 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	d7815651-6b14-41f6-90cd-0a5b0b4a12ac	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Fair 140 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	59331429-5fe0-4671-aabd-ec20640dd3ee	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Fair 125 C	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	c6ef3b07-babf-401d-a241-4e81e162c965	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 330 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	c6d4b851-bf09-4177-b473-a2378c55ceec	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Light 210 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	2f151e6c-ab2d-40cb-a67c-e067147ed702	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Light 280 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	6b0b9204-f205-415b-bd16-1970958b8be7	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Light 240 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	8c12a34c-f648-4b55-8265-d430c72ae205	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Light 250 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	0b1c20e6-9d98-4b69-8fe0-ac5e9f2b9b2c	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 370 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	b8d4862e-2671-4b85-8338-f935e0d0194f	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 310 C	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	8d53abee-73bc-4268-b08d-0c196ff4d852	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 375 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	1de296f5-276b-4e8f-8db2-78ea01965c4a	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 610 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	75543b93-8ed9-4c7b-9fcf-99745df5a194	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 620 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	798eecb3-ff6e-46d1-9053-b40e9cd02e5c	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 640 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	cbf949b3-e640-48eb-acf6-fccd6f258865	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 650 C	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	b8bfad36-54b7-42f3-bb5b-5eda1a10f021	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 660 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	853100ea-a9dc-43eb-9715-125b543d2be0	2025-10-31	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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