Gentak
- Product NDC
- 63187-873
- 11-digit product format
- 631870873
- Labeler code
- 63187
- Product ID
- 63187-873_57dbd129-b76f-49e6-b76a-eb86ad22273b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gentamicin Sulfate
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- Proficient Rx LP
- Application
- ANDA064093
- Marketing category
- ANDA
- Marketing start
- 2006-05-08
- Substance
- GENTAMICIN SULFATE
- Active strength
- 3 mg/g
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gentak
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GENTAMICIN SULFATE | 3 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8X7386QRLV |
| Rxcui | 310466, 545236 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-873-35 | Gentak | 1 in 1 CARTON | OINTMENT | 1 | | 3 |
| 63187-873-35 | Gentak | 3.5 g in 1 TUBE | OINTMENT | 3.5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-873 | GENTAK (GENTAMICIN SULFATE) OINTMENT [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 2 package rows | 20191113_aebfe247-cdf7-4acb-97b3-6d4341d7c815.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 |
|---|
| 63187-873-35 | 63187087335 | 1 TUBE in 1 CARTON (63187-873-35) / 3.5 g in 1 TUBE | 1 tube | 2017-07-03 | 0000-00-00 | No | No | Current |