Nascobal

Product NDC
49884-270
Requested package NDC
49884-270-82
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

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage49884-27049884-270-82IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021642-001NASCOBALCYANOCOBALAMIN0.5MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD2005-01-31

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021642-001NASCOBAL0.5MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD2005-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021642-001NASCOBAL0.5MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD2005-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021642-001NASCOBAL0.5MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD2005-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD2005-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD2005-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD2005-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD2005-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD2005-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD2005-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD2005-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD2005-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALABRLD, RS2005-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALABRLD, RS2005-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALABRLD, RS2005-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-3187673890dc5c…
2021-03-12 10:30 UTC2021-03N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALABRLD, RS2005-01-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-313f01610625f2…
2019-09-15 20:21 UTC2019-09N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-31b00525d2431f…
2019-07-19 19:46 UTC2019-07N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALABRLD, RS2005-01-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALABRLD, RS2005-01-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALABRLD, RS2005-01-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALABRLD, RS2005-01-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALABRLD, RS2005-01-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALABRLD, RS2005-01-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-313f0d92c62455…
2023-05-13 08:27 UTC2023-05N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-31053a50430f4f…
2023-01-26 05:58 UTC2023-01N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021642-001NASCOBAL0.5MG/SPRAYSPRAY, METERED / NASALRLD, RS2005-01-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021642-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021642-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021642-001AB18072bd15b7f6…
2020-11-12 02:37 UTC2020-11N021642-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021642-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021642-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021642-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021642-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021642-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021642-001AB1a67488948f0b…

Observed Orange Book patent history#

Patent history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021642-00189407142024-02-26U-11522015-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021642-00174044892024-03-12Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021642-00194150072024-07-28U-18962016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021642-00172296362024-08-01U-817Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021642-00178793492024-08-01U-1152Drug product2011-06-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021642-00180033532024-08-01U-8172014-04-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021642-00189407142024-02-26U-11522015-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021642-00174044892024-03-12Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021642-00194150072024-07-28U-18962016-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021642-00172296362024-08-01U-817Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021642-00178793492024-08-01U-1152Drug product2011-06-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021642-00180033532024-08-01U-8172014-04-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021642-00189407142024-02-26U-11522015-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021642-00174044892024-03-12Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021642-00194150072024-07-28U-18962016-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021642-00172296362024-08-01U-817Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021642-00178793492024-08-01U-1152Drug product2011-06-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021642-00180033532024-08-01U-8172014-04-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021642-00189407142024-02-26U-11522015-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021642-00174044892024-03-12Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021642-00194150072024-07-28U-18962016-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021642-00172296362024-08-01U-817Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021642-00178793492024-08-01U-1152Drug product2011-06-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021642-00180033532024-08-01U-8172014-04-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021642-00189407142024-02-26U-11522015-02-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N021642-00174044892024-03-12Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N021642-00194150072024-07-28U-18962016-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N021642-00172296362024-08-01U-817Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N021642-00178793492024-08-01U-1152Drug product2011-06-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N021642-00180033532024-08-01U-8172014-04-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021642-00189407142024-02-26U-11522015-02-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021642-00174044892024-03-12Drug product79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021642-00194150072024-07-28U-18962016-09-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021642-00172296362024-08-01U-817Drug product79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021642-00178793492024-08-01U-1152Drug product2011-06-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021642-00180033532024-08-01U-8172014-04-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021642-00189407142024-02-26U-11522015-02-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021642-00174044892024-03-12Drug product301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021642-00194150072024-07-28U-18962016-09-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021642-00172296362024-08-01U-817Drug product301d65b070ca…

Additional Listing Data#

Finished product
Yes
Brand name base
Nascobal

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYANOCOBALAMIN500 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P6YC3EG204Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
697e0e52-c01b-4b53-9994-f79c46eb6b4fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-270-52Nascobal1 in 1 CARTONSPRAY115
49884-270-82Nascobal4 in 1 CARTONSPRAY415

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-270-52EA - Each49884-2702d14da94-063d-4abe-a45c-1e149f1b8aa812014-08-01
49884-270-82EA - Each49884-270f28256b9-1569-47e4-bf88-14fc8aac531312014-09-03
49884-270-86ML - Milliliter49884-270c09ee6ea-6bb8-4a93-966f-ec8427555e0a12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-270NASCOBAL (CYANOCOBALAMIN) SPRAY [ENDO USA, INC.]14Current NDC, Legacy NDC, 2 package rows20240712_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NascobalCYANOCOBALAMINPar Health USA, LLC697e0e52-c01b-4b53-9994-f79c46eb6b4f2024-03-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 021642
application number: NDA021642
ndc (package): 49884-270-82
ndc (product): 49884-270
ndc11 (package): 49884027082

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861113cyanocobalamin 500 MCG/ACTUAT Nasal SprayPSN697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861115NASCOBAL 500 MCG/ACTUAT Nasal SprayPSN697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861115vitamin B12 0.5 MG/ACTUAT Nasal Spray [Nascobal]SBD697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861113vitamin B12 0.5 MG/ACTUAT Nasal SpraySCD697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861115cyanocobalamin 500 MCG per 0.1 ML Nasal Spray [Nascobal]SY697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861113cyanocobalamin 500 MCG/ACTUAT Nasal SpraySY697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861115Nascobal 0.5 MG/ACTUAT Nasal SpraySY697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861115Nascobal 500 MCG/ACTUAT Nasal SpraySY697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861113vitamin B 12 500 MCG/ACTUAT Nasal SpraySY697e0e52-c01b-4b53-9994-f79c46eb6b4f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-270-82498840270824 SPRAY in 1 CARTON (49884-270-82) 4 spray2009-08-132026-12-31NoNoCurrent