Cromolyn Sodium Oral Solution (Concentrate)
- Product NDC
- 76204-025
- 11-digit product format
- 762040025
- Labeler code
- 76204
- Product ID
- 76204-025_459fa806-53ad-d48e-e063-6394a90af72b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cromolyn Sodium Oral Solution (Concentrate)
- Dosage form
- SOLUTION, CONCENTRATE
- Route
- ORAL
- Labeler
- Ritedose Pharmaceuticals, LLC
- Application
- ANDA209264
- Marketing category
- ANDA
- Marketing start
- 2021-12-01
- Substance
- CROMOLYN SODIUM
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cromolyn Sodium Oral Solution (Concentrate)
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CROMOLYN SODIUM | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q2WXR1I0PK |
| Rxcui | 831261 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76204-025-08 | Cromolyn Sodium Oral Solution (Concentrate) | 5 mL in 1 AMPULE | SOLUTION, CONCENTRATE | 5 | | 10 |
| 76204-025-08 | Cromolyn Sodium Oral Solution (Concentrate) | 8 in 1 POUCH | SOLUTION, CONCENTRATE | 8 | | 10 |
| 76204-025-96 | Cromolyn Sodium Oral Solution (Concentrate) | 12 in 1 CARTON | SOLUTION, CONCENTRATE | 12 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76204-025 | CROMOLYN SODIUM ORAL SOLUTION (CONCENTRATE) SOLUTION, CONCENTRATE [RITEDOSE PHARMACEUTICALS, LLC] | 8 | Current NDC, Legacy NDC, 3 package rows | 20241219_d208df15-c823-6e0d-e053-2a95a90ad1be.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 |
|---|
| 76204-025-08 | 76204002508 | 5 mL in 1 AMPULE | 5 ml | | | | | Historical |
| 76204-025-96 | 76204002596 | 12 POUCH in 1 CARTON (76204-025-96) / 8 AMPULE in 1 POUCH (76204-025-08) / 5 mL in 1 AMPULE | 12 pouch | 2021-12-01 | 0000-00-00 | No | No | Current |