Finacea
- Product NDC
- 50419-825
- 11-digit product format
- 504190825
- Labeler code
- 50419
- Product ID
- 50419-825_b6b1dc01-47b9-45f5-b659-3a2c2d83eecd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azelaic acid
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.
- Application
- NDA021470
- Marketing category
- NDA
- Marketing start
- 2002-12-24
- Marketing end
- 0000-00-00
- Substance
- AZELAIC ACID
- Active strength
- 0 g/g
- Pharmacologic classes
- Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE]
- 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 |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 6c6fc281-9445-2e9e-1c29-a09ddbc4299c | Product name | 2 | 20200213 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 2a856070-cbe7-4f85-be0f-09885ff91196 | Product name | 1 | 20150806 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50419-825-01 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-12c6-a910-e053-dadaa90a0b85 | c7c5af9c-935e-440d-a625-567936e0bae7 |
| 50419-825-02 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-12c6-a910-e053-dadaa90a0b85 | c7c5af9c-935e-440d-a625-567936e0bae7 |
| 50419-825-03 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-12c6-a910-e053-dadaa90a0b85 | c7c5af9c-935e-440d-a625-567936e0bae7 |
| 50419-825-74 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-12c6-a910-e053-dadaa90a0b85 | c7c5af9c-935e-440d-a625-567936e0bae7 |
| 50419-825-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-12c6-a910-e053-dadaa90a0b85 | c7c5af9c-935e-440d-a625-567936e0bae7 |
| 50419-825-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-12c6-a910-e053-dadaa90a0b85 | c7c5af9c-935e-440d-a625-567936e0bae7 |
| 50419-825-03 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-12c6-a910-e053-dadaa90a0b85 | c7c5af9c-935e-440d-a625-567936e0bae7 |
| 50419-825-74 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-12c6-a910-e053-dadaa90a0b85 | c7c5af9c-935e-440d-a625-567936e0bae7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50419-825-02 | GM - Gram | 50419-825 | cc88c1c6-579a-4dbd-b4ae-ffd456903c1e | 1 | 2013-04-01 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1041518 | azelaic acid 15 % Topical Gel | PSN | 9f40cd45-58a6-4376-9220-84bfe7d7e358 | 3 |
| 1043748 | Finacea 15 % Topical Gel | PSN | 9f40cd45-58a6-4376-9220-84bfe7d7e358 | 3 |
| 1043748 | azelaic acid 0.15 MG/MG Topical Gel [Finacea] | SBD | 9f40cd45-58a6-4376-9220-84bfe7d7e358 | 3 |
| 1041518 | azelaic acid 0.15 MG/MG Topical Gel | SCD | 9f40cd45-58a6-4376-9220-84bfe7d7e358 | 3 |
| 1041518 | azelaic acid 15 % Topical Gel | SY | 9f40cd45-58a6-4376-9220-84bfe7d7e358 | 3 |
| 1043748 | Finacea 0.15 MG/MG Topical Gel | SY | 9f40cd45-58a6-4376-9220-84bfe7d7e358 | 3 |
| 1043748 | Finacea 15 % Topical Gel | SY | 9f40cd45-58a6-4376-9220-84bfe7d7e358 | 3 |
| 1043748 | Finacea Plus (azelaic acid 0.15 MG/MG) Topical Gel | SY | 9f40cd45-58a6-4376-9220-84bfe7d7e358 | 3 |