DEXTENZA
- Product NDC
- 70382-204
- 11-digit product format
- 703820204
- Labeler code
- 70382
- Product ID
- 70382-204_ad2305a4-f888-4800-a31e-1fff3ffee20d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dexamethasone
- Dosage form
- INSERT
- Route
- INTRACANALICULAR; OPHTHALMIC
- Labeler
- Ocular Therapeutix, Inc.
- Application
- NDA208742
- Marketing category
- NDA
- Marketing start
- 2019-01-07
- Substance
- DEXAMETHASONE
- Active strength
- .4 mg/1
- Pharmacologic classes
- 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
- DEXTENZA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXAMETHASONE | .4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7S5I7G3JQL |
| Rxcui | 2108015, 2108020 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70382-204-01 | DEXTENZA | 1 in 1 BOX, UNIT-DOSE | INSERT | 1 | | 18 |
| 70382-204-10 | DEXTENZA | 10 in 1 BOX, UNIT-DOSE | INSERT | 10 | | 18 |
| 70382-204-88 | DEXTENZA | 1 in 1 POUCH | INSERT | 1 | | 18 |
| 70382-204-99 | DEXTENZA | 1 in 1 BOX, UNIT-DOSE | INSERT | 1 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70382-204 | DEXTENZA (DEXAMETHASONE) INSERT [OCULAR THERAPEUTIX, INC.
] | 17 | Current NDC, Legacy NDC, 4 package rows | 20250420_7514e6b8-c33f-4fbf-8810-ef520e1eb4bd.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 |
|---|
| 70382-204-01 | 70382020401 | 1 POUCH in 1 BOX, UNIT-DOSE (70382-204-01) / 1 INSERT in 1 POUCH (70382-204-88) | 1 pouch | 2019-01-07 | 0000-00-00 | No | No | Current |
| 70382-204-10 | 70382020410 | 10 POUCH in 1 BOX, UNIT-DOSE (70382-204-10) / 1 INSERT in 1 POUCH (70382-204-88) | 10 pouch | 2019-01-07 | 0000-00-00 | No | No | Current |
| 70382-204-88 | 70382020488 | 1 in 1 POUCH | | | | | | Historical |
| 70382-204-99 | 70382020499 | 1 POUCH in 1 BOX, UNIT-DOSE (70382-204-99) / 1 INSERT in 1 POUCH (70382-204-88) | 1 pouch | 2019-01-07 | 0000-00-00 | No | No | Current |