Systane
- Product NDC
- 0065-0474
- 11-digit product format
- 000650474
- Labeler code
- 0065
- Product ID
- 0065-0474_634b9bdb-004a-462e-ba48-1ab306157e02
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- hypromellose
- Dosage form
- GEL
- Route
- OPHTHALMIC
- Labeler
- Alcon Laboratories, Inc.
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-12-15
- Substance
- HYPROMELLOSE 2910 (4000 MPA.S)
- Active strength
- 3 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Systane
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYPROMELLOSE 2910 (4000 MPA.S) | 3 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RN3152OP35 |
| Rxcui | 310932 |
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Hypromellose 2910 (4000 Mpa.s) | ACTIVE INGREDIENT | RN3152OP35 | SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.] | 1 | |
| Hypromellose 2910 (4000 Mpa.s) | ACTIVE MOIETY | RN3152OP35 | SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.] | 1 | |
| Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) | INACTIVE INGREDIENT | 4Q93RCW27E | SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.] | 1 | |
| Phosphonic Acid | INACTIVE INGREDIENT | 35V6A8JW8E | SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.] | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.] | 1 | |
| Sodium Perborate | INACTIVE INGREDIENT | Y52BK1W96C | SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.] | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0065-0474 | SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.] | 9 | Current NDC, Legacy NDC, 4 package rows | 20231216_5f74b161-ae41-d0e2-6ed9-8deca55d2c0f.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 |
|---|
| 0065-0474-01 | 00065047401 | 1 TUBE in 1 CARTON (0065-0474-01) / 10 g in 1 TUBE | 1 tube | 2012-12-15 | 0000-00-00 | No | No | Current |
| 0065-0474-02 | 00065047402 | 3.5 g in 1 TUBE | 3.5 g | | | | | Historical |