Home NDC 49884-270-82 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 49884-270 49884-270-82 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…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-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N021642-001 NASCOBAL CYANOCOBALAMIN 0.5MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL RLD 2005-01-31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# 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49884-270-82 49884027082 4 SPRAY in 1 CARTON (49884-270-82) 4 spray 2009-08-13 2026-12-31 No No Current