Active ingredient
Cromolyn
11 finished FDA listings contain Cromolyn as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CROMOLYN SODIUM
- Dosage forms
- Liquid, Solution, Solution, Concentrate, Solution/ Drops, Spray, Metered
- Routes
- Intrabronchial, Nasal, Ophthalmic, Oral
- Manufacturers / labelers
- 11
- Strengths listed
- 100 mg/5ml · 20 mg/2ml · 20 mg/ml · 40 mg/ml · 5.2 mg/1
- Brand names in FDA listings
- Gastrocrom, Nasalcrom
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 42612
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020479 | VIATRIS SPECIALTY | 1996-02-29 | 1 |
| ANDA 075282 | SANDOZ | 1999-06-16 | 4 |
| ANDA 075271 | TEVA PHARMS | 2000-01-18 | 1 |
| ANDA 075702 | BAUSCH AND LOMB | 2001-07-03 | 2 |
| ANDA 202583 | RISING | 2011-10-27 | 1 |
| ANDA 202745 | MICRO LABS LTD INDIA | 2013-04-04 | 1 |
| ANDA 209264 | AILEX PHARMS LLC | 2017-10-16 | 1 |
Official labeling on DailyMed
- CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC] · version 7 · 2026-08-04
- NASALCROM (CROMOLYN SODIUM) SPRAY, METERED [PRESTIGE BRANDS HOLDINGS, INC.] · version 14 · 2026-06-03
- CROMOLYN SODIUM SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS INC.] · version 5 · 2026-04-02
- CROMOLYN SODIUM SOLUTION, CONCENTRATE [OMNIVIUM PHARMACEUTICALS LLC] · version 2 · 2026-01-21
- GASTROCROM (CROMOLYN SODIUM) LIQUID [VIATRIS SPECIALTY LLC] · version 6 · 2025-08-22
- CROMOLYN SODIUM SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS] · version 14 · 2024-11-08
- CROMOLYN SODIUM SOLUTION, CONCENTRATE [MICRO LABS LIMITED] · version 12 · 2024-09-27
- CROMOLYN SODIUM SOLUTION [TEVA PHARMACEUTICALS USA, INC.] · version 9 · 2024-02-01
- CROMOLYN SODIUM SPRAY, METERED [BAUSCH & LOMB INCORPORATED] · version 8 · 2023-02-01
- CROMOLYN SODIUM SOLUTION, CONCENTRATE [RISING PHARMA HOLDINGS, INC.] · version 7 · 2022-01-17
- CROMOLYN SODIUM SOLUTION/ DROPS [PROFICIENT RX LP] · version 2 · 2019-10-15
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.