VUSION

Product NDC: 0378-8222
11-digit product format: 003788222
Labeler code: 0378
Product ID: 0378-8222_1b5de1cf-d19f-424b-86c0-e2ebcb0b3cf0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: miconazole nitrate, zinc oxide, white petrolatum
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Mylan Pharmaceuticals Inc.
Application: NDA021026
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-11-06
Marketing end: 2026-12-31
Substance: MICONAZOLE NITRATE; PETROLATUM; ZINC OXIDE
Active strength: 2.5; 813.5; 150 mg/g; mg/g; mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Current FDA listing: 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
N021026-001	VUSION	MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE	0.25%;81.35%;15%	OINTMENT / TOPICAL		RLD, RS	2006-02-16

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021026-001	8147852	2028-03-30	U-1426		2013-09-11

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: VUSION

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICONAZOLE NITRATE	2.5 mg/g
ZINC OXIDE	813.5 mg/g
PETROLATUM	150 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VW4H1CYW1K	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup
4T6H12BN9U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
831391	Internal RxNorm lookup
831393	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
b026bc7d-3a18-41e8-88c4-1e063cd2f42c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-8222-50	VUSION	50 g in 1 TUBE	OINTMENT	50		3
0378-8222-50	VUSION	1 in 1 CARTON	OINTMENT	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-8222-50	GM - Gram	0378-8222	52903dae-91dc-45d2-91cf-b54cecc3f837	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-8222	VUSION (MICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUM) OINTMENT [MYLAN PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 2 package rows	20250522_b026bc7d-3a18-41e8-88c4-1e063cd2f42c.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
VUSION	MICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUM	Mylan Pharmaceuticals Inc.	b44b452d-3630-4cb5-8ed1-1f8edac4690c	2018-08-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021026 application number: NDA021026
VUSION	MICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUM	Mylan Pharmaceuticals Inc.	b026bc7d-3a18-41e8-88c4-1e063cd2f42c	2018-08-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021026 application number: NDA021026 ndc (product): 0378-8222

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VW4H1CYW1K	MICONAZOLE NITRATE	22832-87-7	MICONAZOLE NITRATE
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
831391	miconazole nitrate 0.25 % / zinc oxide 15 % / petrolatum 81.4 % Topical Ointment	PSN	b026bc7d-3a18-41e8-88c4-1e063cd2f42c	3
831393	Vusion 0.25 % / 15 % / 81.35 % Topical Ointment	PSN	b026bc7d-3a18-41e8-88c4-1e063cd2f42c	3
831393	miconazole nitrate 0.0025 MG/MG / petrolatum 0.814 MG/MG / zinc oxide 0.15 MG/MG Topical Ointment [Vusion]	SBD	b026bc7d-3a18-41e8-88c4-1e063cd2f42c	3
831391	miconazole nitrate 0.0025 MG/MG / petrolatum 0.814 MG/MG / zinc oxide 0.15 MG/MG Topical Ointment	SCD	b026bc7d-3a18-41e8-88c4-1e063cd2f42c	3
831391	Miconazole Nitrate 0.0025 MG/MG / Petrolatum 0.814 MG/MG / ZNO 0.15 MG/MG Topical Ointment	SY	b026bc7d-3a18-41e8-88c4-1e063cd2f42c	3
831393	Miconazole Nitrate 0.0025 MG/MG / Petrolatum 0.814 MG/MG / ZNO 0.15 MG/MG Topical Ointment [Vusion]	SY	b026bc7d-3a18-41e8-88c4-1e063cd2f42c	3
831391	miconazole nitrate 0.25 % / petrolatum, white 81.35 % / zinc oxide 15 % Topical Ointment	SY	b026bc7d-3a18-41e8-88c4-1e063cd2f42c	3
831393	Vusion (miconazole nitrate 0.25 % / petrolatum, white 81.35 % / zinc oxide 15 % ) Topical Ointment	SY	b026bc7d-3a18-41e8-88c4-1e063cd2f42c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-8222-50	00378822250	1 TUBE in 1 CARTON (0378-8222-50) / 50 g in 1 TUBE	1 tube	2018-11-06	2026-12-31	No	No	Current