Synarel
- Product NDC
- 0025-0166
- 11-digit product format
- 000250166
- Labeler code
- 0025
- Product ID
- 0025-0166_0ce07394-417b-4592-a051-8d63bdafbada
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nafarelin acetate
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA019886
- Marketing category
- NDA
- Marketing start
- 1990-02-13
- Substance
- NAFARELIN ACETATE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Synarel
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAFARELIN ACETATE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ENZ0QJW4H |
| Rxcui | 1797878, 1797880 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0025-0166-08 | Synarel | 1 in 1 CARTON | SPRAY, METERED | 1 | | 23 |
| 0025-0166-08 | Synarel | 8 mL in 1 BOTTLE, SPRAY | SPRAY, METERED | 8 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAFARELIN ACETATE | ACTIVE INGREDIENT | 8ENZ0QJW4H | SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 12 | |
| NAFARELIN | ACTIVE MOIETY | 1X0094V6JV | SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 12 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 12 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 12 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 12 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 12 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 12 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0025-0166 | SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [PFIZER LABORATORIES DIV PFIZER INC] | 21 | Current NDC, Legacy NDC, 2 package rows | 20230301_d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0025-0166-08 | 00025016608 | 1 BOTTLE, SPRAY in 1 CARTON (0025-0166-08) / 8 mL in 1 BOTTLE, SPRAY | 1990-02-13 | 0000-00-00 | No | No | Current |