Fluocinonide
- Product NDC
- 43386-095
- 11-digit product format
- 433860095
- Labeler code
- 43386
- Product ID
- 43386-095_6f782dc3-8de2-41d2-9644-584482d9ee8b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinonide
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA207538
- Marketing category
- ANDA
- Marketing start
- 2017-07-31
- Marketing end
- 0000-00-00
- Substance
- FLUOCINONIDE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a338afdd-91bc-4c45-5113-8b445b8e6cf2 | Product name | 5 | 20200618 |
| f3bf4e6e-291f-4372-8e90-b4047949153a | Product name | 3 | 20200514 |
| 934e8c63-e34a-6dfb-4224-efad2d76fafc | Product name | 5 | 20190405 |
| ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfe | Product name | 1 | 20181219 |
| ef1d202f-16bf-4f17-a390-087db27f5314 | Product name | 1 | 20181203 |
| de14082b-1b4a-48ac-b75c-4ee3ff8a29be | Product name | 1 | 20180809 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43386-095-60 | 2024-01-30 | C162847 | 48780-1 | 1030e365-45b2-111a-e063-dadaa90a10e2 | Fluocinonide Ointment USP, 0.05% Rx only |
| 43386-095-61 | 2024-01-30 | C162847 | 48780-1 | 1030e365-45b2-111a-e063-dadaa90a10e2 | Fluocinonide Ointment USP, 0.05% Rx only |
| 43386-095-62 | 2024-01-30 | C162847 | 48780-1 | 1030e365-45b2-111a-e063-dadaa90a10e2 | Fluocinonide Ointment USP, 0.05% Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43386-095-60 | Fluocinonide | 15 g in 1 TUBE | OINTMENT | 15 | 1 | |
| 43386-095-60 | Fluocinonide | 1 in 1 CARTON | OINTMENT | 1 | 1 | |
| 43386-095-61 | Fluocinonide | 60 g in 1 TUBE | OINTMENT | 60 | 1 | |
| 43386-095-61 | Fluocinonide | 1 in 1 CARTON | OINTMENT | 1 | 1 | |
| 43386-095-62 | Fluocinonide | 30 g in 1 TUBE | OINTMENT | 30 | 1 | |
| 43386-095-62 | Fluocinonide | 1 in 1 CARTON | OINTMENT | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43386-095-60 | GM - Gram | 43386-095 | ee551c9c-8b31-49fe-b032-be2f8e271bfc | 1 | 2019-04-11 |
| 43386-095-61 | GM - Gram | 43386-095 | cb9f13e0-7e5a-4e5f-8103-8974ee9d1a2f | 1 | 2019-04-11 |
| 43386-095-62 | GM - Gram | 43386-095 | a7bb46aa-8e44-4e7c-8e01-9db5fa199730 | 1 | 2019-04-11 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 103457 | fluocinonide 0.05 % Topical Ointment | PSN | 62a9a299-79a6-4cd8-b2e6-643dfcff200a | 1 |
| 103457 | fluocinonide 0.0005 MG/MG Topical Ointment | SCD | 62a9a299-79a6-4cd8-b2e6-643dfcff200a | 1 |
| 103457 | fluocinonide 0.05 % Topical Ointment | SY | 62a9a299-79a6-4cd8-b2e6-643dfcff200a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43386-095-60 | 43386009560 | 1 TUBE in 1 CARTON (43386-095-60) > 15 g in 1 TUBE | 1 tube | 2017-07-31 | 0000-00-00 | No | No | Current |
| 43386-095-61 | 43386009561 | 1 TUBE in 1 CARTON (43386-095-61) > 60 g in 1 TUBE | 1 tube | 2017-07-31 | 0000-00-00 | No | No | Current |
| 43386-095-62 | 43386009562 | 1 TUBE in 1 CARTON (43386-095-62) > 30 g in 1 TUBE | 1 tube | 2017-07-31 | 0000-00-00 | No | No | Current |