Neo-Synalar
- Product NDC
- 43538-940
- 11-digit product format
- 435380940
- Labeler code
- 43538
- Product ID
- 43538-940_b176bc29-53fc-48a1-bf09-ba250f1d13d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- neomycin sulfate and fluocinolone acetonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Eurofarma, Inc.
- Application
- ANDA060700
- Marketing category
- ANDA
- Marketing start
- 1963-06-11
- Substance
- FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE
- Active strength
- .25; 3.5 mg/g; mg/g
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Neo-Synalar
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOCINOLONE ACETONIDE | .25 mg/g |
| NEOMYCIN SULFATE | 3.5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0CD5FD6S2M, 057Y626693 |
| Rxcui | 1191359, 1542994 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43538-940-60 | Neo-Synalar | 60 g in 1 TUBE | CREAM | 60 | | 5 |
| 43538-940-60 | Neo-Synalar | 1 in 1 CARTON | CREAM | 1 | | 5 |
| 43538-940-99 | Neo-Synalar | 4 in 1 CARTON | CREAM | 4 | | 5 |
| 43538-940-99 | Neo-Synalar | 3 g in 1 TUBE | CREAM | 3 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43538-940 | NEO-SYNALAR (NEOMYCIN SULFATE AND FLUOCINOLONE ACETONIDE) CREAM [MEDIMETRIKS PHARMACEUTICALS] | 4 | Current NDC, Legacy NDC, 4 package rows | 20230315_1141956e-8a4c-4f80-95d1-f15bdb57fdf6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43538-940-60 | 43538094060 | 1 TUBE in 1 CARTON (43538-940-60) / 60 g in 1 TUBE | 1 tube | 1963-06-11 | 0000-00-00 | No | No | Current |
| 43538-940-99 | 43538094099 | 4 TUBE in 1 CARTON (43538-940-99) / 3 g in 1 TUBE | 4 tube | 1963-06-11 | 0000-00-00 | No | No | Current |