FLUTICASONE PROPIONATE
- Product NDC
- 68462-937
- 11-digit product format
- 684620937
- Labeler code
- 68462
- Product ID
- 68462-937_78b85a2f-69c2-4066-a43c-33873d570c14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluticasone propionate
- Dosage form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA219602
- Marketing category
- ANDA
- Marketing start
- 2026-03-24
- Substance
- FLUTICASONE PROPIONATE
- Active strength
- 44 ug/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FLUTICASONE PROPIONATE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FLUTICASONE PROPIONATE | 44 ug/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | O2GMZ0LF5W |
| Rxcui | 895994 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33 | Product name | 3 | 20260126 |
| 343e8617-eb68-1e10-cfa9-8c30af285764 | Product name | 3 | 20240513 |
| a31ad3df-8021-2ea1-94eb-0fe2f49b7729 | Product name | 4 | 20220719 |
| 813fe018-3e3c-40e4-8f71-7ab50f3dfe81 | Product name | 2 | 20180723 |
| 3bcd721e-0555-4bc3-96c6-690471ff9d94 | Product name | 1 | 20171113 |
| 9f9452df-fa34-43d4-97fe-c6605344c5a8 | Product name | 1 | 20171113 |
| 0e5a25a6-9f05-44b5-8449-aa63e59f7202 | Product name | 1 | 20170426 |
| f3c5232f-03de-44f5-996a-90cd9c08bc60 | Product name | 1 | 20170426 |
| 1cb17fbb-0da4-2841-37bc-e7079783e1a2 | Product name | 1 | 20140508 |
| 667f427a-8698-a508-767a-53ed61b4c2e9 | Product name | 1 | 20140508 |
| 6a97ffc8-1d4d-a971-4978-85ba3a22eac9 | Product name | 1 | 20140508 |
| 6df84e13-2223-fa46-1e26-17e2f58a1e1c | Product name | 1 | 20140508 |
| 90fec588-984c-4375-cfd4-7e40114bdf80 | Product name | 1 | 20140508 |
| 9c1d3c48-b162-204b-f55b-e0f25c31c52e | Product name | 1 | 20140508 |
| 9fdb6139-394b-1510-4baf-bde68c419789 | Product name | 1 | 20140508 |
| aef26912-037b-9a4e-db49-225ef6dfd8f1 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68462-937-20 | FLUTICASONE PROPIONATE | 120 in 1 INHALER | AEROSOL, METERED | 120 | 2 | |
| 68462-937-20 | FLUTICASONE PROPIONATE | 1 in 1 CARTON | AEROSOL, METERED | 1 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68462-937-20 | GM - Gram | 68462-937 | ce80b0e4-6d5f-4aeb-bd51-5d0be3effbb5 | 1 | 2026-04-20 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 895994 | fluticasone propionate 44 MCG/INHAL Metered Dose Inhaler, 120 Actuations | PSN | 27a9b531-f0fd-44ee-b197-ac4b7d64b30c | 2 |
| 895994 | 120 ACTUAT fluticasone propionate 0.044 MG/ACTUAT Metered Dose Inhaler | SCD | 27a9b531-f0fd-44ee-b197-ac4b7d64b30c | 2 |
| 895994 | fluticasone propionate 0.044 MG/ACTUAT Metered Dose Inhaler, 120 ACTUAT | SY | 27a9b531-f0fd-44ee-b197-ac4b7d64b30c | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68462-937-20 | 68462093720 | 1 INHALER in 1 CARTON (68462-937-20) / 120 AEROSOL, METERED in 1 INHALER | 1 inhaler | 2026-03-24 | No | No | Current |