Home NDC 60635-118 Varithena
Product NDC 60635-118
11-digit product format 606350118
Labeler code 60635
Product ID 60635-118_5455a54e-bbb4-4c02-ab6e-e9815136548e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name polidocanol
Dosage form KIT
Labeler Boston Scientific Corporation
Application NDA205098
Marketing category NDA
Marketing start 2014-07-10
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 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 product product 60635-118 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 60635-118 60635-118-01 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205098-001 VARITHENA POLIDOCANOL 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 N205098-002 VARITHENA POLIDOCANOL 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205098-001 7814943 2027-11-19 U-1461 Drug product N205098-001 9480652 2032-05-12 Drug product 2016-11-30
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 3 · 84 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 2026-08-18 06:07:40 2026-07 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2017-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205098-001 VARITHENA 180MG/18ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2013-11-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N205098-002 VARITHENA 77.5MG/7.75ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-12-21 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 6 · 226 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N205098-001 7814943 2027-11-19 U-1461 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205098-001 7814943 2027-11-19 U-1461 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205098-001 7814943 2027-11-19 U-1461 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205098-001 7814943 2027-11-19 U-1461 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205098-001 7814943 2027-11-19 U-1461 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205098-001 7814943 2027-11-19 U-1461 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205098-001 8122917 2024-09-09 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205098-001 7731986 2024-11-17 U-1463 Drug substance, Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205098-001 7814943 2027-11-19 U-1461 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205098-001 8122917 2024-09-09 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205098-001 7731986 2024-11-17 U-1463 Drug substance, Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205098-001 7814943 2027-11-19 U-1461 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205098-001 8122917 2024-09-09 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205098-001 7731986 2024-11-17 U-1463 Drug substance, Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205098-001 7814943 2027-11-19 U-1461 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205098-001 8122917 2024-09-09 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205098-001 7731986 2024-11-17 U-1463 Drug substance, Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205098-001 7814943 2027-11-19 U-1461 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205098-001 8122917 2024-09-09 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205098-001 7731986 2024-11-17 U-1463 Drug substance, Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205098-001 7814943 2027-11-19 U-1461 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205098-001 8122917 2024-09-09 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205098-001 7731986 2024-11-17 U-1463 Drug substance, Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205098-001 7814943 2027-11-19 U-1461 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205098-001 8122917 2024-09-09 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205098-001 7731986 2024-11-17 U-1463 Drug substance, Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205098-001 7814943 2027-11-19 U-1461 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205098-001 9480652 2032-05-12 Drug product 2016-11-30 301d65b070ca…
Additional Listing Data#
Finished product Yes
Brand name base Varithena
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1485068 Internal RxNorm lookup 1485070 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# Effective, Related label table Effective Related label 2022-12-21 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 2022-12-21 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 2022-12-21 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 2022-07-29 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 2022-07-29 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 2022-07-29 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 2020-07-22 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 2020-07-22 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 2020-07-22 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 2020-03-12 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 2020-03-12 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 2020-03-12 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 2020-01-31 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 2020-01-31 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013 2020-01-31 These highlights do not include all the information needed to use VARITHENA® safely and effectively. See Full Prescribing Information for VARITHENA. VARITHENA (polidocanol injectable foam), for intravenous use Initial U.S. Approval: 2013
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60635-018-01 Varithena 18 mL in 1 CANISTER INJECTABLE FOAM 18 mL 10 mg in 1mL 17 60635-118-01 Varithena 1 in 1 POUCH KIT 1 17 60635-118-01 Varithena 1 in 1 CARTON KIT 1 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POLIDOCANOL ACTIVE INGREDIENT 0AWH8BFG9A VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5 POLIDOCANOL ACTIVE MOIETY 0AWH8BFG9A VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5 ALCOHOL INACTIVE INGREDIENT 3K9958V90M VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5 CARBON DIOXIDE INACTIVE INGREDIENT 142M471B3J VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5 OXYGEN INACTIVE INGREDIENT S88TT14065 VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5 POTASSIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 4J9FJ0HL51 VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5 SODIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT 94255I6E2T VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60635-118 VARITHENA (POLIDOCANOL) KIT [BIOCOMPATIBLES, INC.] 14 Current NDC, Legacy NDC, 3 package rows 20241012_dfd6b4a0-b0dc-11e2-9e96-0800200c9a66.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 60635-018-01 60635001801 18 mL in 1 CANISTER 18 ml Historical 60635-118-01 60635011801 1 POUCH in 1 CARTON (60635-118-01) / 1 KIT in 1 POUCH * 18 mL in 1 CANISTER (60635-018-01) * 303 mL in 1 CANISTER 1 pouch 2016-06-22 0000-00-00 No No Current