Home NDC 46287-024 POTASSIUM PHOSPHATES
Product NDC 46287-024
11-digit product format 462870024
Labeler code 46287
Product ID 46287-024_994a32ae-32b1-4fbb-ac7a-ea8530e93801
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name monobasic potassium phosphate and dibasic potassium phosphate
Dosage form INJECTION
Route INTRAVENOUS
Labeler CMP PHARMA, INC.
Application NDA212121
Marketing category NDA
Marketing start 2019-09-19
Marketing end 0000-00-00
Substance POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC
Active strength 175 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2020-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 46287-024-15 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 46287-024-10 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 46287-024-15 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 46287-024-10 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 46287-024-15 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 46287-024-10 1332a3947898…d4bfe170f9cd…
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 N212121-001 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD 2019-09-19
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04
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.
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 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD 2019-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD 2019-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD 2019-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD 2019-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD 2019-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD 2019-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD 2019-09-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD 2019-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N212121-001 POTASSIUM PHOSPHATES 4500MG/15ML (300MG/ML);2650MG/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-09-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212121-001 POTASSIUM PHOSPHATES 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) SOLUTION / INTRAVENOUS RLD 2019-09-19 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212121-001 10632150 2039-04-19 U-2789 Drug product 2020-05-04 a50c72e98297…
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46287-024 POTASSIUM PHOSPHATES (MONOBASIC POTASSIUM PHOSPHATE AND DIBASIC POTASSIUM PHOSPHATE) INJECTION [CMP PHARMA, INC.] 4 Legacy NDC 20240530_2c2078d1-9edc-4d0c-a72a-5491c28a5aac.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 46287-024-10 46287002410 10 VIAL, SINGLE-DOSE in 1 CARTON (46287-024-10) > 15 mL in 1 VIAL, SINGLE-DOSE 2019-09-19 0000-00-00 No No Current 46287-024-15 46287002415 1 VIAL, SINGLE-DOSE in 1 CARTON (46287-024-15) > 15 mL in 1 VIAL, SINGLE-DOSE 2019-09-19 0000-00-00 No No Current