Fluocinonide Cream
- Product NDC
- 69238-1534
- 11-digit product format
- 692381534
- Labeler code
- 69238
- Product ID
- 69238-1534_64167760-d963-439f-ac85-21eefb5e8b39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA210554
- Marketing category
- ANDA
- Marketing start
- 2017-10-01
- Substance
- FLUOCINONIDE
- Active strength
- .5 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluocinonide Cream
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FLUOCINONIDE | .5 mg/g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 2W4A77YPAN |
| Rxcui | 103456 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| a338afdd-91bc-4c45-5113-8b445b8e6cf2 | Product name | 5 | 20200618 |
| f3bf4e6e-291f-4372-8e90-b4047949153a | Product name | 3 | 20200514 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 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 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69238-1534-2 | Fluocinonide Cream | 120 g in 1 TUBE | CREAM | 120 | 8 | |
| 69238-1534-2 | Fluocinonide Cream | 1 in 1 CARTON | CREAM | 1 | 8 | |
| 69238-1534-3 | Fluocinonide Cream | 1 in 1 CARTON | CREAM | 1 | 8 | |
| 69238-1534-3 | Fluocinonide Cream | 30 g in 1 TUBE | CREAM | 30 | 8 | |
| 69238-1534-5 | Fluocinonide Cream | 15 g in 1 TUBE | CREAM | 15 | 8 | |
| 69238-1534-5 | Fluocinonide Cream | 1 in 1 CARTON | CREAM | 1 | 8 | |
| 69238-1534-6 | Fluocinonide Cream | 60 g in 1 TUBE | CREAM | 60 | 8 | |
| 69238-1534-6 | Fluocinonide Cream | 1 in 1 CARTON | CREAM | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69238-1534-2 | GM - Gram | 69238-1534 | 99939f19-b2b3-4970-82a0-f3b9f9bf38f7 | 1 | 2021-08-05 |
| 69238-1534-3 | GM - Gram | 69238-1534 | ee745d46-0de1-4815-934d-0fc80b15409a | 1 | 2021-08-05 |
| 69238-1534-5 | GM - Gram | 69238-1534 | 56955223-56e7-4d87-9fb8-97608622f2dd | 1 | 2021-08-05 |
| 69238-1534-6 | GM - Gram | 69238-1534 | 51a259ca-6a92-447f-a5ee-b25314f28556 | 1 | 2021-08-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69238-1534 | FLUOCINONIDE CREAM (FLUOCINONIDE) CREAM [AMNEAL PHARMACEUTICALS NY LLC] | 8 | Current NDC, Legacy NDC, 8 package rows | 20240404_817cac6b-fec5-406d-aa0c-8852d08a3c65.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 103456 | fluocinonide 0.05 % Topical Cream | PSN | 817cac6b-fec5-406d-aa0c-8852d08a3c65 | 8 |
| 103456 | fluocinonide 0.5 MG/ML Topical Cream | SCD | 817cac6b-fec5-406d-aa0c-8852d08a3c65 | 8 |
| 103456 | fluocinonide 0.05 % Topical Cream | SY | 817cac6b-fec5-406d-aa0c-8852d08a3c65 | 8 |
| 103456 | fluocinonide 0.05 % Topical Cream | PSN | b1b4a6e9-814e-41e9-9f35-8bed7595265b | 4 |
| 103456 | fluocinonide 0.5 MG/ML Topical Cream | SCD | b1b4a6e9-814e-41e9-9f35-8bed7595265b | 4 |
| 103456 | fluocinonide 0.05 % Topical Cream | SY | b1b4a6e9-814e-41e9-9f35-8bed7595265b | 4 |
| 103456 | fluocinonide 0.05 % Topical Cream | PSN | ab79df76-192b-422e-8d2c-dd5a46ffb216 | 2 |
| 103456 | fluocinonide 0.5 MG/ML Topical Cream | SCD | ab79df76-192b-422e-8d2c-dd5a46ffb216 | 2 |
| 103456 | fluocinonide 0.05 % Topical Cream | SY | ab79df76-192b-422e-8d2c-dd5a46ffb216 | 2 |
| 103456 | fluocinonide 0.05 % Topical Cream | PSN | db86f8bd-1537-f6dd-e053-2a95a90a672e | 1 |
| 103456 | fluocinonide 0.05 % Topical Cream | PSN | e5bf009d-b80b-60f3-e053-2995a90a6d66 | 1 |
| 103456 | fluocinonide 0.5 MG/ML Topical Cream | SCD | db86f8bd-1537-f6dd-e053-2a95a90a672e | 1 |
| 103456 | fluocinonide 0.5 MG/ML Topical Cream | SCD | e5bf009d-b80b-60f3-e053-2995a90a6d66 | 1 |
| 103456 | fluocinonide 0.05 % Topical Cream | SY | db86f8bd-1537-f6dd-e053-2a95a90a672e | 1 |
| 103456 | fluocinonide 0.05 % Topical Cream | SY | e5bf009d-b80b-60f3-e053-2995a90a6d66 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69238-1534-2 | 69238153402 | 1 TUBE in 1 CARTON (69238-1534-2) / 120 g in 1 TUBE | 1 tube | 2017-10-01 | 0000-00-00 | No | No | Current |
| 69238-1534-3 | 69238153403 | 1 TUBE in 1 CARTON (69238-1534-3) / 30 g in 1 TUBE | 1 tube | 2017-10-01 | 0000-00-00 | No | No | Current |
| 69238-1534-5 | 69238153405 | 1 TUBE in 1 CARTON (69238-1534-5) / 15 g in 1 TUBE | 1 tube | 2017-10-01 | 0000-00-00 | No | No | Current |
| 69238-1534-6 | 69238153406 | 1 TUBE in 1 CARTON (69238-1534-6) / 60 g in 1 TUBE | 1 tube | 2017-10-01 | 0000-00-00 | No | No | Current |