Premier Value

Product NDC: 68016-070
Requested package NDC: 68016-070-09
11-digit product format: 680160070
Labeler code: 68016
Product ID: 68016-070_b4cb8843-8811-4d06-989c-8aceeff009b7
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: CREAM
Route: VAGINAL
Labeler: Pharmacy Value Alliance LLC
Application: ANDA076773
Marketing category: ANDA
Marketing start: 2005-03-02
Marketing end: 0000-00-00
Substance: MICONAZOLE NITRATE
Active strength: 40 mg/g
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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
excluded package	package	68016-070	68016-070-09	I	Inactivated by FDA		2026-08-11

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68016-070	68016-070-09	I	Inactivated by FDA		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68016-070	68016-070-09	I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A076773-001	MICONAZOLE 3	MICONAZOLE NITRATE	4%	CREAM / VAGINAL			2005-03-02

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68016-070-09	2025-07-29	C162847	48780-1	3b156c62-3371-fb37-e063-e6dba90a4e07	Premier Value ® Miconazole 3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-070-09	Premier Value Miconazole 3	1 in 1 CARTON	CREAM	1		3
68016-070-09	Premier Value Miconazole 3	25 g in 1 TUBE, WITH APPLICATOR	CREAM	25		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Miconazole Nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	PREMIER VALUE MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM]	2
Miconazole	ACTIVE MOIETY	7NNO0D7S5M	PREMIER VALUE MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM]	2
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	PREMIER VALUE MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM]	2
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	PREMIER VALUE MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM]	2
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	PREMIER VALUE MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM]	2
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PREMIER VALUE MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM]	2
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	PREMIER VALUE MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PREMIER VALUE MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM]	2
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	PREMIER VALUE MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM]	2
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	PREMIER VALUE MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM]	2
water	INACTIVE INGREDIENT	059QF0KO0R	PREMIER VALUE MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [CHAIN DRUG CONSORTIUM]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-070	PREMIER VALUE MICONAZOLE 3 (MICONAZOLE NITRATE) CREAM [PHARMACY VALUE ALLIANCE LLC]	3	Legacy NDC, 2 package rows	20170615_4c326c90-97a3-4c57-ac92-6621b8895c8e.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole 3	MICONAZOLE NITRATE	TARGET Corporation	12a2e441-4fdf-4c5e-b033-ba05ef12fc2f	2025-07-18	Warnings	Exact identifier application applno (ANDA): 076773 application number: ANDA076773
Lagicam antifungal	MICONAZOLE NITRATE	Genomma Lab USA, Inc.	85043273-7411-48f5-8ad4-3f00e03cafa3	2025-07-02	Warnings	Exact identifier application applno (ANDA): 076773 application number: ANDA076773
Miconazole Nitrate	MICONAZOLE NITRATE	Sun Pharmaceutical Industries, Inc.	eaca3e39-6ea0-4d7e-803c-db22024ad9f9	2025-07-01	Warnings	Exact identifier application applno (ANDA): 076773 application number: ANDA076773

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VW4H1CYW1K	MICONAZOLE NITRATE	22832-87-7	MICONAZOLE NITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
998544	miconazole nitrate 4 % Vaginal Cream	PSN	4c326c90-97a3-4c57-ac92-6621b8895c8e	3
998544	miconazole nitrate 40 MG/ML Vaginal Cream	SCD	4c326c90-97a3-4c57-ac92-6621b8895c8e	3
998544	miconazole nitrate 4 % Vaginal Cream	SY	4c326c90-97a3-4c57-ac92-6621b8895c8e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68016-070-09	68016007009	1 TUBE, WITH APPLICATOR in 1 CARTON (68016-070-09) > 25 g in 1 TUBE, WITH APPLICATOR	2005-03-02	0000-00-00	No	No	Current