Cromolyn Sodium
- Product NDC
- 68788-8490
- 11-digit product format
- 687888490
- Labeler code
- 68788
- Product ID
- 68788-8490_378bf83b-f080-45f8-a53a-0dc2f32f4cac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cromolyn Sodium
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA075282
- Marketing category
- ANDA
- Marketing start
- 2023-07-21
- Substance
- CROMOLYN SODIUM
- Active strength
- 40 mg/mL
- Pharmacologic classes
- Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cromolyn Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CROMOLYN SODIUM | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q2WXR1I0PK |
| Rxcui | 831109 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8490-1 | Cromolyn Sodium | 10 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8490 | CROMOLYN SODIUM SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, 1 package rows | 20250312_18892411-465f-4d8d-9550-7dafa6c6a0a3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8490-1 | 68788849001 | 10 mL in 1 BOTTLE, PLASTIC (68788-8490-1) | 10 ml | 2023-07-21 | No | No | Historical |