Home NDC 67919-040 SIVEXTRO
Product NDC 67919-040
11-digit product format 679190040
Labeler code 67919
Product ID 67919-040_340a4655-ccf2-4c0f-a305-7576c06f4518
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tedizolid phosphate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Merck Sharp & Dohme LLC
Application NDA205436
Marketing category NDA
Marketing start 2014-06-20
Substance TEDIZOLID PHOSPHATE
Active strength 200 mg/4mL
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N205436-001 SIVEXTRO TEDIZOLID PHOSPHATE 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205436-001 8420676 2028-02-23 U-282 Drug substance, Drug product 2014-07-03 N205436-001 7816379 2028-06-20 U-2507 Drug substance, Drug product 2014-07-03 N205436-001 10065947 2030-02-03 Drug product 2019-04-09 N205436-001 10442829 2030-02-03 Drug substance 2019-11-13 N205436-001 9624250 2030-02-03 U-2507 Drug substance, Drug product 2019-04-09 N205436-001 9988406 2030-02-03 Drug product 2019-04-09 N205436-001 8426389 2030-12-31 U-282 Drug substance, Drug product 2014-07-03
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N205436-001 NPP 2028-04-04
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 · 43 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 2026-09-14 22:38:34 2026-08 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205436-001 SIVEXTRO 200MG/VIAL POWDER / INTRAVENOUS RLD, RS 2014-06-20 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 8 · 298 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N205436-001 8420676 2028-02-23 U-282 Drug substance, Drug product 2014-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205436-001 7816379 2028-06-20 U-2507 Drug substance, Drug product 2014-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205436-001 10065947 2030-02-03 Drug product 2019-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205436-001 10442829 2030-02-03 Drug substance 2019-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205436-001 9624250 2030-02-03 U-2507 Drug substance, Drug product 2019-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205436-001 9988406 2030-02-03 Drug product 2019-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205436-001 8426389 2030-12-31 U-282 Drug substance, Drug product 2014-07-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205436-001 8420676 2028-02-23 U-282 Drug substance, Drug product 2014-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205436-001 7816379 2028-06-20 U-2507 Drug substance, Drug product 2014-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205436-001 10065947 2030-02-03 Drug product 2019-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205436-001 10442829 2030-02-03 Drug substance 2019-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205436-001 9624250 2030-02-03 U-2507 Drug substance, Drug product 2019-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205436-001 9988406 2030-02-03 Drug product 2019-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205436-001 8426389 2030-12-31 U-282 Drug substance, Drug product 2014-07-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205436-001 8420676 2028-02-23 U-282 Drug substance, Drug product 2014-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205436-001 7816379 2028-06-20 U-2507 Drug substance, Drug product 2014-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205436-001 10065947 2030-02-03 Drug product 2019-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205436-001 10442829 2030-02-03 Drug substance 2019-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205436-001 9624250 2030-02-03 U-2507 Drug substance, Drug product 2019-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205436-001 9988406 2030-02-03 Drug product 2019-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205436-001 8426389 2030-12-31 U-282 Drug substance, Drug product 2014-07-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205436-001 8420676 2028-02-23 U-282 Drug substance, Drug product 2014-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205436-001 7816379 2028-06-20 U-2507 Drug substance, Drug product 2014-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205436-001 10065947 2030-02-03 Drug product 2019-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205436-001 10442829 2030-02-03 Drug substance 2019-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205436-001 9624250 2030-02-03 U-2507 Drug substance, Drug product 2019-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205436-001 9988406 2030-02-03 Drug product 2019-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205436-001 8426389 2030-12-31 U-282 Drug substance, Drug product 2014-07-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205436-001 8420676 2028-02-23 U-282 Drug substance, Drug product 2014-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205436-001 7816379 2028-06-20 U-2507 Drug substance, Drug product 2014-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205436-001 10065947 2030-02-03 Drug product 2019-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205436-001 10442829 2030-02-03 Drug substance 2019-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205436-001 9624250 2030-02-03 U-2507 Drug substance, Drug product 2019-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205436-001 9988406 2030-02-03 Drug product 2019-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205436-001 8426389 2030-12-31 U-282 Drug substance, Drug product 2014-07-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205436-001 8420676 2028-02-23 U-282 Drug substance, Drug product 2014-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205436-001 7816379 2028-06-20 U-2507 Drug substance, Drug product 2014-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205436-001 10065947 2030-02-03 Drug product 2019-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205436-001 10442829 2030-02-03 Drug substance 2019-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205436-001 9624250 2030-02-03 U-2507 Drug substance, Drug product 2019-04-09 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 96 observed states.
Additional Listing Data#
Finished product Yes
Brand name base SIVEXTRO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TEDIZOLID PHOSPHATE 200 mg/4mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O7DRJ6R4DW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1540862 Internal RxNorm lookup 1540868 Internal RxNorm lookup 1540886 Internal RxNorm lookup 1540890 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67919-040-02 SIVEXTRO 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 34 67919-040-02 SIVEXTRO 4 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 4 34
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded tedizolid phosphate ACTIVE INGREDIENT O7DRJ6R4DW SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 6 tedizolid ACTIVE MOIETY 97HLQ82NGL SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 6 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 6 crospovidone (15 MPA.S AT 5%) INACTIVE INGREDIENT 68401960MK SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 6 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 6 hydrochloric acid INACTIVE INGREDIENT QTT17582CB SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 6 magnesium stearate INACTIVE INGREDIENT 70097M6I30 SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 6 mannitol INACTIVE INGREDIENT 3OWL53L36A SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 6 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 6 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 6 povidones INACTIVE INGREDIENT FZ989GH94E SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 6 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 6 talc INACTIVE INGREDIENT 7SEV7J4R1U SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 6 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67919-040 SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC] 31 Current NDC, Legacy NDC, 2 package rows 20250419_75672079-589f-451a-bdbf-eaebcfcc80a9.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 Marketing start Marketing end Sample Exclude flag Status 67919-040-01 67919004001 10 VIAL, GLASS in 1 CARTON (67919-040-01) > 4 mL in 1 VIAL, GLASS 2014-06-20 0000-00-00 No No Current 67919-040-02 67919004002 10 VIAL, GLASS in 1 CARTON (67919-040-02) / 4 mL in 1 VIAL, GLASS 2014-06-20 No No Current