timolol maleate
- Product NDC
- 72603-540
- 11-digit product format
- 726030540
- Labeler code
- 72603
- Product ID
- 72603-540_1226c91d-666c-4d6a-9af3-7f12efe1a15f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- timolol maleate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- NorthStar RxLLC
- Application
- ANDA078771
- Marketing category
- ANDA
- Marketing start
- 2024-12-01
- Substance
- TIMOLOL MALEATE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- timolol maleate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIMOLOL MALEATE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P8Y54F701R |
| Rxcui | 1992303 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72603-540-01 | timolol maleate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 1 |
| 72603-540-01 | timolol maleate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-540 | TIMOLOL MALEATE SOLUTION/ DROPS [NORTHSTAR RXLLC] | 1 | Current NDC, 2 package rows | 20241202_9db7322d-eb31-4fff-9b14-8a0294d01704.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-540-01 | 72603054001 | 1 BOTTLE, DROPPER in 1 CARTON (72603-540-01) / 5 mL in 1 BOTTLE, DROPPER | 2024-12-01 | No | No | Historical |