Fluticasone Propionate and Salmeterol
- Product NDC
- 66993-586
- 11-digit product format
- 669930586
- Labeler code
- 66993
- Product ID
- 66993-586_0318e892-0db1-4a82-a649-9e530a2d1d05
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluticasone propionate and salmeterol
- Dosage form
- POWDER
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Prasco Laboratories
- Application
- NDA021077
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-02-08
- Substance
- FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
- Active strength
- 500; 50 ug/1; ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021077-001 | ADVAIR DISKUS 100/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 |
| N021077-002 | ADVAIR DISKUS 250/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 |
| N021077-003 | ADVAIR DISKUS 500/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021077-001 | AB |
| N021077-002 | AB |
| N021077-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021077-001 | ADVAIR DISKUS 100/50 | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021077-002 | ADVAIR DISKUS 250/50 | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021077-003 | ADVAIR DISKUS 500/50 | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021077-001 | ADVAIR DISKUS 100/50 | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021077-002 | ADVAIR DISKUS 250/50 | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021077-003 | ADVAIR DISKUS 500/50 | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021077-001 | ADVAIR DISKUS 100/50 | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021077-002 | ADVAIR DISKUS 250/50 | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021077-003 | ADVAIR DISKUS 500/50 | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021077-001 | ADVAIR DISKUS 100/50 | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021077-002 | ADVAIR DISKUS 250/50 | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021077-003 | ADVAIR DISKUS 500/50 | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021077-001 | ADVAIR DISKUS 100/50 | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021077-002 | ADVAIR DISKUS 250/50 | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021077-003 | ADVAIR DISKUS 500/50 | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021077-001 | ADVAIR DISKUS 100/50 | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021077-002 | ADVAIR DISKUS 250/50 | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021077-003 | ADVAIR DISKUS 500/50 | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021077-001 | ADVAIR DISKUS 100/50 | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021077-002 | ADVAIR DISKUS 250/50 | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021077-003 | ADVAIR DISKUS 500/50 | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021077-001 | ADVAIR DISKUS 100/50 | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021077-002 | ADVAIR DISKUS 250/50 | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021077-003 | ADVAIR DISKUS 500/50 | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021077-001 | ADVAIR DISKUS 100/50 | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021077-002 | ADVAIR DISKUS 250/50 | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021077-003 | ADVAIR DISKUS 500/50 | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021077-001 | ADVAIR DISKUS 100/50 | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021077-002 | ADVAIR DISKUS 250/50 | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021077-003 | ADVAIR DISKUS 500/50 | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021077-001 | ADVAIR DISKUS 100/50 | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021077-002 | ADVAIR DISKUS 250/50 | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021077-003 | ADVAIR DISKUS 500/50 | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021077-001 | ADVAIR DISKUS 100/50 | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021077-002 | ADVAIR DISKUS 250/50 | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021077-003 | ADVAIR DISKUS 500/50 | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021077-001 | ADVAIR DISKUS 100/50 | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021077-002 | ADVAIR DISKUS 250/50 | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021077-003 | ADVAIR DISKUS 500/50 | 0.5MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021077-001 | ADVAIR DISKUS 100/50 | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER / INHALATION | AB | RLD, RS | 2000-08-24 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021077-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021077-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021077-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021077-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021077-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021077-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021077-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021077-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021077-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021077-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021077-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021077-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021077-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021077-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021077-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021077-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021077-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021077-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021077-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021077-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021077-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021077-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021077-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021077-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021077-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021077-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021077-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021077-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021077-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021077-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021077-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021077-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021077-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021077-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021077-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021077-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021077-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021077-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021077-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021077-001 | AB | 1 | 8072bd15b7f6… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021077-001 | M-214 | 2020-12-20 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021077-002 | M-214 | 2020-12-20 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021077-003 | M-214 | 2020-12-20 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N021077-001 | M-214 | 2020-12-20 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021077-002 | M-214 | 2020-12-20 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021077-003 | M-214 | 2020-12-20 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021077-001 | M-214 | 2020-12-20 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021077-002 | M-214 | 2020-12-20 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021077-003 | M-214 | 2020-12-20 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021077-001 | M-214 | 2020-12-20 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021077-002 | M-214 | 2020-12-20 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021077-003 | M-214 | 2020-12-20 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021077-001 | M-214 | 2020-12-20 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021077-002 | M-214 | 2020-12-20 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021077-003 | M-214 | 2020-12-20 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021077-001 | M-214 | 2020-12-20 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021077-002 | M-214 | 2020-12-20 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021077-003 | M-214 | 2020-12-20 | ea99ee380514… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluticasone Propionate and Salmeterol
- Brand name suffix
- DISKUS
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FLUTICASONE PROPIONATE | 500 ug/1 |
| SALMETEROL XINAFOATE | 50 ug/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| O2GMZ0LF5W | Internal UNII lookup |
| 6EW8Q962A5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66993-586-97 | Fluticasone Propionate and SalmeterolDISKUS | 1 in 1 CARTON | POWDER | 1 | 14 | |
| 66993-586-97 | Fluticasone Propionate and SalmeterolDISKUS | 60 in 1 INHALER | POWDER | 60 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66993-586-97 | EA - Each | 66993-586 | 85abef82-4746-4a61-8b04-993180c76396 | 1 | 2019-03-12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66993-586 | FLUTICASONE PROPIONATE AND SALMETEROL DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [PRASCO LABORATORIES] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240711_6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ADVAIR DISKUS | FLUTICASONE PROPIONATE AND SALMETEROL | A-S Medication Solutions | cf306656-0d4c-4edd-9d6a-3471f99484e6 | 2026-04-26 | Warnings, Adverse reactions | 021077 NDA021077 |
| ADVAIR DISKUS | FLUTICASONE PROPIONATE AND SALMETEROL | GlaxoSmithKline LLC | 4eeb5f6a-593f-4a9e-9692-adefa2caf8fc | 2026-03-26 | Warnings, Adverse reactions | 021077 NDA021077 |
| Fluticasone Propionate and Salmeterol DISKUS | FLUTICASONE PROPIONATE AND SALMETEROL | REMEDYREPACK INC. | 0a2d1344-f412-41db-9b54-0c92a0743703 | 2026-02-04 | Warnings, Adverse reactions | 021077 NDA021077 |
| ADVAIR DISKUS | FLUTICASONE PROPIONATE AND SALMETEROL | A-S Medication Solutions | 17dd0a86-8161-4aa9-9b90-a23d81b38164 | 2025-08-08 | Warnings, Adverse reactions | 021077 NDA021077 |
| Fluticasone Propionate and Salmeterol DISKUS | FLUTICASONE PROPIONATE AND SALMETEROL | REMEDYREPACK INC. | 197b7628-71aa-4fa2-94df-d617c0f2c986 | 2025-08-05 | Warnings, Adverse reactions | 021077 NDA021077 |
| Fluticasone Propionate and Salmeterol DISKUS | FLUTICASONE PROPIONATE AND SALMETEROL | REMEDYREPACK INC. | 1ce604aa-2535-4a3c-a64d-092f5d4f8194 | 2025-08-05 | Warnings, Adverse reactions | 021077 NDA021077 |
| ADVAIR DISKUS | FLUTICASONE PROPIONATE AND SALMETEROL | A-S Medication Solutions | 7c9c722b-68ac-4bda-ad99-50e3fb1c58c8 | 2024-01-30 | Warnings, Adverse reactions | 021077 NDA021077 |
| Fluticasone Propionate and Salmeterol DISKUS | FLUTICASONE PROPIONATE AND SALMETEROL | A-S Medication Solutions | 9e237635-6975-4930-9ce1-051d9e3bf615 | 2024-01-22 | Warnings, Adverse reactions | 021077 NDA021077 |
| Fluticasone Propionate and Salmeterol DISKUS | FLUTICASONE PROPIONATE AND SALMETEROL | Prasco Laboratories | 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc | 2023-07-19 | Warnings, Adverse reactions | 021077 NDA021077 66993-586 |
| ADVAIR DISKUS | FLUTICASONE PROPIONATE AND SALMETEROL | A-S Medication Solutions | a6d87760-4744-41d5-bfee-db3b996b7294 | 2023-05-16 | Warnings, Adverse reactions | 021077 NDA021077 |
| Fluticasone Propionate and Salmeterol DISKUS | FLUTICASONE PROPIONATE AND SALMETEROL | A-S Medication Solutions | 2dfadeac-6599-41c5-8e25-5f78cba17f00 | 2023-02-06 | Warnings, Adverse reactions | 021077 NDA021077 |
| Fluticasone Propionate and Salmeterol DISKUS | FLUTICASONE PROPIONATE AND SALMETEROL | A-S Medication Solutions | ccf98c0a-fc40-4e08-bdf2-145fe4537db5 | 2023-02-06 | Warnings, Adverse reactions | 021077 NDA021077 |
| Fluticasone Propionate and Salmeterol DISKUS | FLUTICASONE PROPIONATE AND SALMETEROL | Proficient Rx LP | 6915bd5d-b792-4b1b-8221-7eeb0a8638ba | 2020-01-01 | Warnings, Adverse reactions | 021077 NDA021077 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 896184 | fluticasone propionate/salmeterol 100/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters | PSN | 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc | 14 |
| 896209 | fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters | PSN | 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc | 14 |
| 896228 | fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters | PSN | 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc | 14 |
| 896184 | 60 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler | SCD | 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc | 14 |
| 896209 | 60 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler | SCD | 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc | 14 |
| 896228 | 60 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler | SCD | 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc | 14 |
| 896184 | fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc | 14 |
| 896209 | fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc | 14 |
| 896228 | fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc | 14 |
| 896184 | fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc | 14 |
| 896209 | fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc | 14 |
| 896228 | fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc | 14 |
| 896228 | fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters | PSN | ccf98c0a-fc40-4e08-bdf2-145fe4537db5 | 9 |
| 896228 | 60 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler | SCD | ccf98c0a-fc40-4e08-bdf2-145fe4537db5 | 9 |
| 896228 | fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | ccf98c0a-fc40-4e08-bdf2-145fe4537db5 | 9 |
| 896228 | fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | ccf98c0a-fc40-4e08-bdf2-145fe4537db5 | 9 |
| 896228 | fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters | PSN | 197b7628-71aa-4fa2-94df-d617c0f2c986 | 1 |
| 896228 | 60 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler | SCD | 197b7628-71aa-4fa2-94df-d617c0f2c986 | 1 |
| 896228 | fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 197b7628-71aa-4fa2-94df-d617c0f2c986 | 1 |
| 896228 | fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT | SY | 197b7628-71aa-4fa2-94df-d617c0f2c986 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 66993-586-97 | 66993058697 | 1 INHALER in 1 CARTON (66993-586-97) / 60 POWDER in 1 INHALER | 1 inhaler | 2019-02-08 | 0000-00-00 | No | No | Current |