Nascobal

Product NDC: 49884-270
11-digit product format: 498840270
Labeler code: 49884
Product ID: 49884-270_bd8722ab-7ac0-4e01-8244-36e8d83eca8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cyanocobalamin
Dosage form: SPRAY
Route: NASAL
Labeler: ENDO USA, Inc.
Application: NDA021642
Marketing category: NDA
Marketing start: 2009-08-13
Marketing end: 2026-12-31
Substance: CYANOCOBALAMIN
Active strength: 500 ug/1
Pharmacologic classes: Vitamin B 12 [CS], Vitamin B12 [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49884-270		D	Discontinued by firm	2026-08-10
excluded package	package	49884-270	49884-270-52	D	Discontinued by firm	2026-08-10
excluded package	package	49884-270	49884-270-86	D	Discontinued by firm	2026-08-10

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-270-52	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-270-86	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-270-52	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-270-86	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-270-52	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-270-86	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-270-52	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-270-86	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-270-52	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-270-86	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-270-52	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-270-86	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-270-52	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-270-86	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-270-52	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-270-86	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-270-52	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-270-86	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49884-270-52	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49884-270-86	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49884-270-52	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49884-270-86	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49884-270-52	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49884-270-86	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49884-270-82	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021642-001	NASCOBAL	CYANOCOBALAMIN	0.5MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2005-01-31

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 2 · 41 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	N021642-001	NASCOBAL	0.5MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2005-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021642-001	NASCOBAL	0.5MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2005-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021642-001	NASCOBAL	0.5MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2005-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD	2005-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2005-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021642-001	NASCOBAL	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2005-01-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021642-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021642-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021642-001	AB	1	`8072bd15b7f6…`
2020-11-12 02:37 UTC	2020-11	N021642-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021642-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021642-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021642-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021642-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021642-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021642-001	AB	1	`a67488948f0b…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021642-001	8940714	2024-02-26	U-1152		2015-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021642-001	7404489	2024-03-12		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021642-001	9415007	2024-07-28	U-1896		2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021642-001	7229636	2024-08-01	U-817	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021642-001	7879349	2024-08-01	U-1152	Drug product	2011-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021642-001	8003353	2024-08-01	U-817		2014-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021642-001	8940714	2024-02-26	U-1152		2015-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021642-001	7404489	2024-03-12		Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021642-001	9415007	2024-07-28	U-1896		2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021642-001	7229636	2024-08-01	U-817	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021642-001	7879349	2024-08-01	U-1152	Drug product	2011-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021642-001	8003353	2024-08-01	U-817		2014-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021642-001	8940714	2024-02-26	U-1152		2015-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021642-001	7404489	2024-03-12		Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021642-001	9415007	2024-07-28	U-1896		2016-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021642-001	7229636	2024-08-01	U-817	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021642-001	7879349	2024-08-01	U-1152	Drug product	2011-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021642-001	8003353	2024-08-01	U-817		2014-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021642-001	8940714	2024-02-26	U-1152		2015-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021642-001	7404489	2024-03-12		Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021642-001	9415007	2024-07-28	U-1896		2016-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021642-001	7229636	2024-08-01	U-817	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021642-001	7879349	2024-08-01	U-1152	Drug product	2011-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021642-001	8003353	2024-08-01	U-817		2014-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021642-001	8940714	2024-02-26	U-1152		2015-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021642-001	7404489	2024-03-12		Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021642-001	9415007	2024-07-28	U-1896		2016-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021642-001	7229636	2024-08-01	U-817	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021642-001	7879349	2024-08-01	U-1152	Drug product	2011-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021642-001	8003353	2024-08-01	U-817		2014-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021642-001	8940714	2024-02-26	U-1152		2015-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021642-001	7404489	2024-03-12		Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021642-001	9415007	2024-07-28	U-1896		2016-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021642-001	7229636	2024-08-01	U-817	Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021642-001	7879349	2024-08-01	U-1152	Drug product	2011-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021642-001	8003353	2024-08-01	U-817		2014-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021642-001	8940714	2024-02-26	U-1152		2015-02-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021642-001	7404489	2024-03-12		Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021642-001	9415007	2024-07-28	U-1896		2016-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021642-001	7229636	2024-08-01	U-817	Drug product		`301d65b070ca…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nascobal

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CYANOCOBALAMIN	500 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P6YC3EG204	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861113	Internal RxNorm lookup
861115	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
697e0e52-c01b-4b53-9994-f79c46eb6b4f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8	Product name	2	20240805
d206bb34-ea65-399d-70d9-834f22dc2c18	Product name	3	20170724
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
49884-270-86	2025-02-01	9d75b9d0-8602-f424-e053-dadaa90a57ce	0a6178f6-48af-4a1d-9b35-c3c2663d0b10
49884-270-52	2022-10-03	e4f33bdf-b341-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use NASCOBAL ® NASAL SPRAY safely and effectively. See full prescribing information for NASCOBAL ® NASAL SPRAY. NASCOBAL (cyanocobalamin nasal spray) Initial U.S. Approval: 1942
49884-270-82	2022-10-03	e4f33bdf-b341-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use NASCOBAL ® NASAL SPRAY safely and effectively. See full prescribing information for NASCOBAL ® NASAL SPRAY. NASCOBAL (cyanocobalamin nasal spray) Initial U.S. Approval: 1942
49884-270-52	2022-07-29	e4f33bdf-b341-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use NASCOBAL ® NASAL SPRAY safely and effectively. See full prescribing information for NASCOBAL ® NASAL SPRAY. NASCOBAL (cyanocobalamin nasal spray) Initial U.S. Approval: 1942
49884-270-82	2022-07-29	e4f33bdf-b341-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use NASCOBAL ® NASAL SPRAY safely and effectively. See full prescribing information for NASCOBAL ® NASAL SPRAY. NASCOBAL (cyanocobalamin nasal spray) Initial U.S. Approval: 1942
49884-270-86	2020-01-31	9d75b9d0-8602-f424-e053-dadaa90a57ce	0a6178f6-48af-4a1d-9b35-c3c2663d0b10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49884-270-52	Nascobal	1 in 1 CARTON	SPRAY	1		15
49884-270-82	Nascobal	4 in 1 CARTON	SPRAY	4		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-270-52	EA - Each	49884-270	2d14da94-063d-4abe-a45c-1e149f1b8aa8	1	2014-08-01
49884-270-82	EA - Each	49884-270	f28256b9-1569-47e4-bf88-14fc8aac5313	1	2014-09-03
49884-270-86	ML - Milliliter	49884-270	c09ee6ea-6bb8-4a93-966f-ec8427555e0a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CYANOCOBALAMIN	ACTIVE INGREDIENT	P6YC3EG204	NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]	15
CYANOCOBALAMIN	ACTIVE MOIETY	P6YC3EG204	NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]	15
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]	15
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]	15
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]	15
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]	15
CYANOCOBALAMIN	ACTIVE INGREDIENT	P6YC3EG204	NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]	3
CYANOCOBALAMIN	ACTIVE MOIETY	P6YC3EG204	NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-270	NASCOBAL (CYANOCOBALAMIN) SPRAY [ENDO USA, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20240712_697e0e52-c01b-4b53-9994-f79c46eb6b4f.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nascobal	CYANOCOBALAMIN	Par Health USA, LLC	697e0e52-c01b-4b53-9994-f79c46eb6b4f	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021642 application number: NDA021642 ndc (product): 49884-270

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P6YC3EG204	CYANOCOBALAMIN	68-19-9	CYANOCOBALAMIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861113	cyanocobalamin 500 MCG/ACTUAT Nasal Spray	PSN	697e0e52-c01b-4b53-9994-f79c46eb6b4f	15
861115	NASCOBAL 500 MCG/ACTUAT Nasal Spray	PSN	697e0e52-c01b-4b53-9994-f79c46eb6b4f	15
861115	vitamin B12 0.5 MG/ACTUAT Nasal Spray [Nascobal]	SBD	697e0e52-c01b-4b53-9994-f79c46eb6b4f	15
861113	vitamin B12 0.5 MG/ACTUAT Nasal Spray	SCD	697e0e52-c01b-4b53-9994-f79c46eb6b4f	15
861115	cyanocobalamin 500 MCG per 0.1 ML Nasal Spray [Nascobal]	SY	697e0e52-c01b-4b53-9994-f79c46eb6b4f	15
861113	cyanocobalamin 500 MCG/ACTUAT Nasal Spray	SY	697e0e52-c01b-4b53-9994-f79c46eb6b4f	15
861115	Nascobal 0.5 MG/ACTUAT Nasal Spray	SY	697e0e52-c01b-4b53-9994-f79c46eb6b4f	15
861115	Nascobal 500 MCG/ACTUAT Nasal Spray	SY	697e0e52-c01b-4b53-9994-f79c46eb6b4f	15
861113	vitamin B 12 500 MCG/ACTUAT Nasal Spray	SY	697e0e52-c01b-4b53-9994-f79c46eb6b4f	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-270-52	49884027052	1 in 1 CARTON						Historical
49884-270-82	49884027082	4 SPRAY in 1 CARTON (49884-270-82)	4 spray	2009-08-13	2026-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nascobal	Par Health USA, LLC	2024-03-01	HUMAN PRESCRIPTION DRUG LABEL	15
Nascobal - Par Pharmaceutical , Inc	Par Pharmaceutical , Inc	2015-02-20	HUMAN PRESCRIPTION DRUG LABEL	15