Home NDC 72000-030 Citric Buffered Normal Saline
Product NDC 72000-030
11-digit product format 720000030
Labeler code 72000
Product ID 72000-030_772b4b36-4627-4087-8a16-c1ed771939c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name anhydrous citric acid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Nabriva Therapeutics US, Inc.
Application NDA211673
Marketing category NDA
Marketing start 2019-09-09
Marketing end 0000-00-00
Substance ANHYDROUS CITRIC ACID
Active strength 166 mg/270mL
Pharmacologic classes Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 72000-030 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 72000-030 72000-030-06 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N211673-001 XENLETA LEFAMULIN ACETATE EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 N211673-001 8071643 2033-03-25 Drug substance, Drug product 2019-09-17 N211673-001 12121582 2036-06-14 Drug product 2025-05-13
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211673-001 NCE 2024-08-19 N211673-001 GAIN 2029-08-19
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 2026-08-18 06:07:40 2026-07 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2019-08-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2019-08-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 92 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 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211673-001 8071643 2033-03-25 Drug substance, Drug product 2019-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211673-001 12121582 2036-06-14 Drug product 2025-05-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211673-001 8071643 2033-03-25 Drug substance, Drug product 2019-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211673-001 12121582 2036-06-14 Drug product 2025-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211673-001 8071643 2033-03-25 Drug substance, Drug product 2019-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211673-001 12121582 2036-06-14 Drug product 2025-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211673-001 8071643 2033-03-25 Drug substance, Drug product 2019-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211673-001 12121582 2036-06-14 Drug product 2025-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211673-001 8071643 2029-01-16 Drug substance, Drug product 2019-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211673-001 8071643 2029-01-16 Drug substance, Drug product 2019-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211673-001 8071643 2029-01-16 Drug substance, Drug product 2019-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211673-001 8071643 2029-01-16 Drug substance, Drug product 2019-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211673-001 8071643 2029-01-16 Drug substance, Drug product 2019-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211673-001 8071643 2029-01-16 Drug substance, Drug product 2019-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211673-001 8071643 2029-01-16 Drug substance, Drug product 2019-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211673-001 8071643 2029-01-16 Drug substance, Drug product 2019-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211673-001 8071643 2029-01-16 Drug substance, Drug product 2019-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211673-001 8071643 2029-01-16 Drug substance, Drug product 2019-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211673-001 8071643 2029-01-16 Drug substance, Drug product 2019-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211673-001 8071643 2029-01-16 Drug substance, Drug product 2019-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211673-001 8071643 2029-01-16 Drug substance, Drug product 2019-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N211673-001 8071643 2029-01-16 Drug substance, Drug product 2019-09-17 4b0b4de00fa7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 82 observed states.
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 72000-030-01 Citric Buffered Normal Saline 270 mL in 1 BAG INJECTION, SOLUTION 270 9 72000-030-06 Citric Buffered Normal Saline 6 in 1 CARTON INJECTION, SOLUTION 6 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72000-030 XENLETA (LEFAMULIN ACETATE) INJECTION, SOLUTION CITRIC BUFFERED NORMAL SALINE (ANHYDROUS CITRIC ACID) INJECTION, SOLUTION XENLETA (LEFAMULIN ACETATE) TABLET, COATED [NABRIVA THERAPEUTICS US, INC.] 9 Legacy NDC, 2 package rows 20241013_101db63d-2fe2-48df-8506-1382d6dcd4a3.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 Xenleta LEFAMULIN ACETATE Meitheal Pharmaceuticals Inc. eb972ea8-7502-422e-84bb-66cb8e93ca06 2026-07-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 211673 application number: NDA211673
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 72000-030-01 72000003001 270 mL in 1 BAG 270 ml Historical 72000-030-06 72000003006 6 BAG in 1 CARTON (72000-030-06) > 270 mL in 1 BAG (72000-030-01) 6 bag 2019-09-09 0000-00-00 No No Current