Cromolyn Sodium
- Product NDC
- 61314-237
- 11-digit product format
- 613140237
- Labeler code
- 61314
- Product ID
- 61314-237_4d6f900a-fa36-445e-80d5-54c8cc5baf34
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cromolyn Sodium
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Sandoz Inc
- Application
- ANDA075282
- Marketing category
- ANDA
- Marketing start
- 1999-06-29
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cromolyn Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CROMOLYN SODIUM | 40 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | Q2WXR1I0PK |
| Rxcui | 831109 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d745b171-bd61-e8c6-cc94-d4add278788b | Product name | 3 | 20230113 |
| a7fea5a7-679e-334b-faff-75e43fb3beb5 | Product name | 2 | 20171208 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61314-237-10 | Cromolyn Sodium | 10 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 10 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61314-237-10 | ML - Milliliter | 61314-237 | dd4db819-272b-42a8-8358-82b81bef6f1c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CROMOLYN SODIUM | ACTIVE INGREDIENT | Q2WXR1I0PK | CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC] | 3 | |
| CROMOLYN | ACTIVE MOIETY | Y0TK0FS77W | CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC] | 3 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC] | 3 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC] | 3 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 831109 | cromolyn sodium 4 % Ophthalmic Solution | PSN | 0d30fb0a-e343-426d-8203-5816bd4cec2f | 14 |
| 831109 | cromolyn sodium 40 MG/ML Ophthalmic Solution | SCD | 0d30fb0a-e343-426d-8203-5816bd4cec2f | 14 |
| 831109 | cromolyn sodium 4 % Ophthalmic Solution | SY | 0d30fb0a-e343-426d-8203-5816bd4cec2f | 14 |
| 831109 | cromolyn sodium 4 % Ophthalmic Solution | PSN | b32851c3-cd97-4be4-a09c-1deab1d6966b | 6 |
| 831109 | cromolyn sodium 40 MG/ML Ophthalmic Solution | SCD | b32851c3-cd97-4be4-a09c-1deab1d6966b | 6 |
| 831109 | cromolyn sodium 4 % Ophthalmic Solution | SY | b32851c3-cd97-4be4-a09c-1deab1d6966b | 6 |
| 831109 | cromolyn sodium 4 % Ophthalmic Solution | PSN | 18892411-465f-4d8d-9550-7dafa6c6a0a3 | 5 |
| 831109 | cromolyn sodium 40 MG/ML Ophthalmic Solution | SCD | 18892411-465f-4d8d-9550-7dafa6c6a0a3 | 5 |
| 831109 | cromolyn sodium 4 % Ophthalmic Solution | SY | 18892411-465f-4d8d-9550-7dafa6c6a0a3 | 5 |
| 831109 | cromolyn sodium 4 % Ophthalmic Solution | PSN | f7a6334c-7b98-4730-8ee6-ca37cf87bba3 | 3 |
| 831109 | cromolyn sodium 40 MG/ML Ophthalmic Solution | SCD | f7a6334c-7b98-4730-8ee6-ca37cf87bba3 | 3 |
| 831109 | cromolyn sodium 4 % Ophthalmic Solution | SY | f7a6334c-7b98-4730-8ee6-ca37cf87bba3 | 3 |
| 831109 | cromolyn sodium 4 % Ophthalmic Solution | PSN | 34ef00e8-0c01-4225-9a40-822ab245752a | 2 |
| 831109 | cromolyn sodium 40 MG/ML Ophthalmic Solution | SCD | 34ef00e8-0c01-4225-9a40-822ab245752a | 2 |
| 831109 | cromolyn sodium 4 % Ophthalmic Solution | SY | 34ef00e8-0c01-4225-9a40-822ab245752a | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61314-237-10 | 61314023710 | 10 mL in 1 BOTTLE, PLASTIC (61314-237-10) | 10 ml | 1999-06-29 | 0000-00-00 | No | No | Current |