Home NDC 71288-040 Citric Buffered Normal Saline
Product NDC 71288-040
11-digit product format 712880040
Labeler code 71288
Product ID 71288-040_b9951406-492b-4420-89cc-24fd655824b3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name anhydrous citric acid
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application NDA211673
Marketing category NDA
Marketing start 2019-09-09
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 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 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 · 42 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 N211673-001 XENLETA EQ 150MG BASE/15ML (EQ 10MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-08-19 84e616aacf4f…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…
Observed Orange Book patent history# Patent history page 1 of 3 · 95 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 N211673-001 8153689 2028-03-19 Drug substance, Drug product 2019-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211673-001 8071643 2033-03-25 Drug substance, Drug product 2019-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211673-001 12121582 2036-06-14 Drug product 2025-05-13 84e616aacf4f…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 84 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Citric Buffered Normal Saline
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANHYDROUS CITRIC ACID 166 mg/270mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HDN0B924X4 Internal UNII lookup XF417D3PSL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2198948 Internal RxNorm lookup 2198953 Internal RxNorm lookup 2198961 Internal RxNorm lookup 2198966 Internal RxNorm lookup 2747671 Internal RxNorm lookup 2747672 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 ndc (product): 71288-040
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71288-040-65 71288004065 6 BAG in 1 CARTON (71288-040-65) / 270 mL in 1 BAG (71288-040-64) 6 bag 2019-09-09 No No Current