cromolyn sodium
- Product NDC
- 51525-0470
- 11-digit product format
- 515250470
- Labeler code
- 51525
- Product ID
- 51525-0470_b70d4285-ddb4-4e80-baf1-340f9572d903
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cromolyn sodium
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA020479
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2015-10-21
- Marketing end
- 2026-06-30
- Substance
- CROMOLYN SODIUM
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- cromolyn sodium
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 |
|---|
| 51525-0470-8 | cromolyn sodium | 8 in 1 POUCH | SOLUTION | 8 | | 9 |
| 51525-0470-8 | cromolyn sodium | 5 mL in 1 AMPULE | SOLUTION | 5 | | 9 |
| 51525-0470-9 | cromolyn sodium | 12 in 1 CARTON | SOLUTION | 12 | | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51525-0470 | CROMOLYN SODIUM SOLUTION [WALLACE PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20240210_fbefd5bd-668a-4d10-b93e-a2e3fc5dddbd.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 |
|---|
| 51525-0470-8 | 51525047008 | 8 in 1 POUCH | | | | | | Historical |
| 51525-0470-9 | 51525047009 | 12 POUCH in 1 CARTON (51525-0470-9) / 8 AMPULE in 1 POUCH (51525-0470-8) / 5 mL in 1 AMPULE | 12 pouch | 2015-10-21 | 2026-06-30 | No | No | Current |