CROMOLYN SODIUM
- Product NDC
- 81665-104
- 11-digit product format
- 816650104
- Labeler code
- 81665
- Product ID
- 81665-104_fd09b0f1-907c-4d4d-a693-9756efd60f20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CROMOLYN SODIUM
- Dosage form
- SOLUTION, CONCENTRATE
- Route
- ORAL
- Labeler
- Omnivium Pharmaceuticals LLC
- Application
- ANDA209264
- Marketing category
- ANDA
- Marketing start
- 2024-08-31
- 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
- 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 | 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 |
|---|
| 81665-104-96 | CROMOLYN SODIUM | 8 in 1 POUCH | SOLUTION, CONCENTRATE | 8 | | 2 |
| 81665-104-96 | CROMOLYN SODIUM | 12 in 1 CARTON | SOLUTION, CONCENTRATE | 12 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81665-104 | CROMOLYN SODIUM SOLUTION, CONCENTRATE [OMNIVIUM PHARMACEUTICALS LLC] | 1 | Current NDC, 2 package rows | 20240911_a742664b-265e-49f9-9744-d04e1fb620ae.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 |
|---|
| 81665-104-96 | 81665010496 | 12 POUCH in 1 CARTON (81665-104-96) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE | 12 pouch | 2024-08-31 | No | No | Historical |