ADVAIR

Product NDC: 21695-196
11-digit product format: 216950196
Labeler code: 21695
Product ID: 21695-196_9e0bdea8-df9b-4873-b24b-919cebff5edd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluticasone propionate and salmeterol
Dosage form: POWDER
Route: ORAL; RESPIRATORY (INHALATION)
Labeler: Rebel Distributors Corp.
Application: NDA021077
Marketing category: NDA
Marketing start: 2001-02-05
Marketing end: 0000-00-00
Substance: SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE
Active strength: 50 ug/1; ug/1
Pharmacologic classes: Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-196		I	Inactivated by FDA		2026-08-11
excluded package	package	21695-196	21695-196-01	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-196-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-196-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-196-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-196-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-196-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-196-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-196-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-196-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-196-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-196-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-196-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-196-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-196-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-196-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-196-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-196-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-196-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-196-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-196-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-196-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-196-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-196-01	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
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#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
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#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
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 table
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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
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
811691fa-281f-6d95-fb49-e2337fb2e146	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-196-01	2019-09-24	C162847	48780-1	934fe258-47b2-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS. ADVAIR DISKUS 100/50 (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) ADVAIR DISKUS 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder) ADVAIR DISKUS 500/50 (fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder) FOR ORAL INHALATION Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-196-01	ADVAIRDISKUS	60 in 1 INHALER	POWDER	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-196-01	EA - Each	21695-196	461fcd58-ade2-4001-900e-4aa8a2c8a376	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUTICASONE PROPIONATE	ACTIVE INGREDIENT	O2GMZ0LF5W	ADVAIR DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [REBEL DISTRIBUTORS CORP.]	1
SALMETEROL XINAFOATE	ACTIVE INGREDIENT	6EW8Q962A5	ADVAIR DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [REBEL DISTRIBUTORS CORP.]	1
FLUTICASONE	ACTIVE MOIETY	CUT2W21N7U	ADVAIR DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [REBEL DISTRIBUTORS CORP.]	1
SALMETEROL	ACTIVE MOIETY	2I4BC502BT	ADVAIR DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [REBEL DISTRIBUTORS CORP.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ADVAIR DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-196	ADVAIR DISKUS (FLUTICASONE PROPIONATE AND SALMETEROL) POWDER [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 1 package rows	20100908_9e0bdea8-df9b-4873-b24b-919cebff5edd.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.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 021077 application number: NDA021077
ADVAIR DISKUS	FLUTICASONE PROPIONATE AND SALMETEROL	GlaxoSmithKline LLC	4eeb5f6a-593f-4a9e-9692-adefa2caf8fc	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021077 application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUS	FLUTICASONE PROPIONATE AND SALMETEROL	REMEDYREPACK INC.	0a2d1344-f412-41db-9b54-0c92a0743703	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021077 application number: NDA021077
ADVAIR DISKUS	FLUTICASONE PROPIONATE AND SALMETEROL	A-S Medication Solutions	17dd0a86-8161-4aa9-9b90-a23d81b38164	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021077 application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUS	FLUTICASONE PROPIONATE AND SALMETEROL	REMEDYREPACK INC.	197b7628-71aa-4fa2-94df-d617c0f2c986	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021077 application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUS	FLUTICASONE PROPIONATE AND SALMETEROL	REMEDYREPACK INC.	1ce604aa-2535-4a3c-a64d-092f5d4f8194	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021077 application number: NDA021077
ADVAIR DISKUS	FLUTICASONE PROPIONATE AND SALMETEROL	A-S Medication Solutions	7c9c722b-68ac-4bda-ad99-50e3fb1c58c8	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021077 application number: 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	Exact identifier application applno (NDA): 021077 application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUS	FLUTICASONE PROPIONATE AND SALMETEROL	Prasco Laboratories	6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc	2023-07-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021077 application number: NDA021077
ADVAIR DISKUS	FLUTICASONE PROPIONATE AND SALMETEROL	A-S Medication Solutions	a6d87760-4744-41d5-bfee-db3b996b7294	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021077 application number: 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	Exact identifier application applno (NDA): 021077 application number: 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	Exact identifier application applno (NDA): 021077 application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUS	FLUTICASONE PROPIONATE AND SALMETEROL	Proficient Rx LP	6915bd5d-b792-4b1b-8221-7eeb0a8638ba	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021077 application number: NDA021077

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6EW8Q962A5	SALMETEROL XINAFOATE	94749-08-3	SALMETEROL XINAFOATE
O2GMZ0LF5W	FLUTICASONE PROPIONATE	80474-14-2	FLUTICASONE PROPIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
896212	ADVAIR DISKUS 250/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters	PSN	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896229	ADVAIR DISKUS 500/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters	PSN	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896209	fluticasone propionate/salmeterol 250/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters	PSN	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896228	fluticasone propionate/salmeterol 500/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters	PSN	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896212	60 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]	SBD	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896229	60 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Advair]	SBD	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896209	60 ACTUAT fluticasone propionate 0.25 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler	SCD	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896228	60 ACTUAT fluticasone propionate 0.5 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler	SCD	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896212	Advair Diskus 250/50 (fluticasone propionate 250 MCG / salmeterol 50 MCG (as salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896212	Advair Diskus 250/50 Dry Powder Inhaler, 60 ACTUAT	SY	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896229	Advair Diskus 500/50 (fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG)) per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896229	Advair Diskus 500/50 Dry Powder Inhaler, 60 ACTUAT	SY	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896209	fluticasone propionate 0.25 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896228	fluticasone propionate 0.5 MG / salmeterol 0.05 MG per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896209	fluticasone propionate 250 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	9e0bdea8-df9b-4873-b24b-919cebff5edd	1
896228	fluticasone propionate 500 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	9e0bdea8-df9b-4873-b24b-919cebff5edd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-196-01	21695019601	60 in 1 INHALER	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ADVAIR DISKUS - Rebel Distributors Corp.	Rebel Distributors Corp.	2010-09-01	HUMAN PRESCRIPTION DRUG LABEL	1