Kovanaze
- Product NDC
- 69803-100
- 11-digit product format
- 698030100
- Labeler code
- 69803
- Product ID
- 69803-100_7aceb111-5e79-5057-e053-2991aa0a9286
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tetracaine hydrochloride and oxymetazoline hydrochloride
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- St. Renatus
- Application
- NDA208032
- Marketing category
- NDA
- Marketing start
- 2016-09-01
- Marketing end
- 0000-00-00
- Substance
- TETRACAINE HYDROCHLORIDE; OXYMETAZOLINE HYDROCHLORIDE
- Active strength
- 30 mg/mL; mg/mL
- Pharmacologic classes
- Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC],Vasoconstrictor [EPC],Vasoconstriction [PE],Increased Sympathetic Activity [PE],Imidazolines [CS]
- 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 |
|---|---|---|---|
| a26f29b9-6919-4f09-a354-491df8d2b97d | Product name | 1 | 20251021 |
| e67be450-f8e4-4bc1-88bd-1259d379f55f | Product name | 1 | 20210127 |
| 122d1fa8-7b9e-49b4-89ce-b062ffd1d947 | Product name | 1 | 20181030 |
| c53f3286-4062-4cf5-8355-399519c639a6 | Product name | 1 | 20170424 |
| a993dfc5-f219-4460-bde6-30dd724d9ef0 | Product name | 1 | 20160818 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69803-100-10 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0e9b-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use KOVANAZE TM NASAL SPRAY safely and effectively. See full prescribing information for KOVANAZE NASAL SPRAY. KOVANAZE (tetracaine HCl and oxymetazoline HCl) Nasal Spray Initial U.S. Approval: 2016 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69803-100-10 | Kovanaze | 30 in 1 CARTON | SPRAY | 30 | 8 | |
| 69803-100-10 | Kovanaze | 0.2 mL in 1 APPLICATOR | SPRAY | 0.2 | 8 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1809056 | KOVANAZE 0.1 MG / 6 MG in 0.2 ML Metered Dose Nasal Spray | PSN | d2af5404-3cfe-445d-8328-19e667ecdc43 | 8 |
| 1809050 | oxymetazoline HCl 0.1 MG / tetracaine HCl 6 MG in 0.2 ML Metered Dose Nasal Spray | PSN | d2af5404-3cfe-445d-8328-19e667ecdc43 | 8 |
| 1809056 | oxymetazoline hydrochloride 0.1 MG/ACTUAT / tetracaine hydrochloride 6 MG/ACTUAT Metered Dose Nasal Spray [Kovanaze] | SBD | d2af5404-3cfe-445d-8328-19e667ecdc43 | 8 |
| 1809050 | oxymetazoline hydrochloride 0.1 MG/ACTUAT / tetracaine hydrochloride 6 MG/ACTUAT Metered Dose Nasal Spray | SCD | d2af5404-3cfe-445d-8328-19e667ecdc43 | 8 |
| 1809056 | Kovanaze (oxymetazoline hydrochloride 0.1 MG / tetracaine hydrochloride 6 MG) per 0.2 ML Metered Dose Nasal Spray | SY | d2af5404-3cfe-445d-8328-19e667ecdc43 | 8 |
| 1809056 | Kovanaze (oxymetazoline hydrochloride 0.1 MG/ACTUAT / tetracaine hydrochloride 6 MG/ACTUAT) Metered Dose Nasal Spray | SY | d2af5404-3cfe-445d-8328-19e667ecdc43 | 8 |
| 1809056 | Kovanaze (oxymetazoline hydrochloride 0.5 MG/ML / tetracaine hydrochloride 30 MG/ML) Metered Dose Nasal Spray | SY | d2af5404-3cfe-445d-8328-19e667ecdc43 | 8 |
| 1809050 | oxymetazoline hydrochloride 0.1 MG / tetracaine hydrochloride 6 MG per 0.2 ML Metered Dose Nasal Spray | SY | d2af5404-3cfe-445d-8328-19e667ecdc43 | 8 |
| 1809050 | oxymetazoline hydrochloride 0.5 MG/ML / tetracaine hydrochloride 30 MG/ML Metered Dose Nasal Spray | SY | d2af5404-3cfe-445d-8328-19e667ecdc43 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 69803-100-10 | 69803010010 | 30 in 1 CARTON | Historical |