National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2012-07-24
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 01:25:19
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0173-0717-22 | GM - Gram | 0173-0717 | 2b9deaef-9cce-4e2b-be3b-55b669fd48cd | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0173-0717 | 0173-0717-22 |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021254-001 | ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | |
| N021254-002 | ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | |
| N021254-003 | ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 301d65b070ca… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-06 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-001 | 7500444 | 2026-02-26 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-002 | 7832351 | 2023-06-19 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-002 | 7832351*PED | 2023-12-19 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-002 | 7500444 | 2026-02-26 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-003 | 7832351 | 2023-06-19 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-003 | 7832351*PED | 2023-12-19 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-003 | 7500444 | 2026-02-26 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-003 | 7500444*PED | 2026-08-26 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-06 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021254-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-001 | 7500444 | 2026-02-26 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-002 | 7832351 | 2023-06-19 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-002 | 7832351*PED | 2023-12-19 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-002 | 7500444 | 2026-02-26 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-003 | 7832351 | 2023-06-19 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-003 | 7832351*PED | 2023-12-19 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-003 | 7500444 | 2026-02-26 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-003 | 7500444*PED | 2026-08-26 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-06 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021254-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-001 | 7500444 | 2026-02-26 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-002 | 7832351 | 2023-06-19 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-002 | 7832351*PED | 2023-12-19 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-002 | 7500444 | 2026-02-26 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-003 | 7832351 | 2023-06-19 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-003 | 7832351*PED | 2023-12-19 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-003 | 7500444 | 2026-02-26 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-003 | 7500444*PED | 2026-08-26 | Pediatric extension | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021254-001 | 7350676*PED | 2019-02-24 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021254-001 | 9861771 | 2020-10-11 | Drug product | 2018-03-22 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021254-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-06 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021254-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 74a2ff9319b5… |
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 HFA | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | GlaxoSmithKline LLC | dfaca6f9-3277-47b2-319d-1377917cb54c | 2024-05-23 | Warnings, Adverse reactions | 0173-0717-22 00173071722 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.