Potassium Phosphate

Product NDC
70069-747
11-digit product format
700690747
Labeler code
70069
Product ID
70069-747_d9961ad1-b332-4cfa-8072-6263917b9788
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA217726
Marketing category
ANDA
Marketing start
2024-07-11
Substance
DIBASIC POTASSIUM PHOSPHATE; MONOBASIC POTASSIUM PHOSPHATE
Active strength
236; 224 mg/mL; mg/mL
Pharmacologic classes
Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217726-001POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11
A217726-002POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A217726-001AP
A217726-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217726-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217726-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217726-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217726-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217726-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217726-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217726-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217726-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217726-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217726-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217726-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217726-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217726-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217726-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217726-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217726-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217726-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217726-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217726-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A217726-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217726-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217726-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217726-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217726-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11301d65b070ca…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217726-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217726-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2024-07-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217726-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217726-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217726-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217726-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217726-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217726-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217726-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217726-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217726-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217726-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217726-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217726-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217726-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217726-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217726-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217726-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217726-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217726-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217726-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217726-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217726-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217726-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217726-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217726-002AP1301d65b070ca…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217726-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217726-002AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONOBASIC POTASSIUM PHOSPHATE236 mg/mL
DIBASIC POTASSIUM PHOSPHATE224 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4J9FJ0HL51Internal UNII lookup
CI71S98N1ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1928567Internal RxNorm lookup
1928569Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
52f07402-1869-4a97-9c92-9729dc611f85Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-747-25Potassium Phosphate25 in 1 CARTONINJECTION, SOLUTION253
70069-747-25Potassium Phosphate15 mL in 1 BOTTLEINJECTION, SOLUTION153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-747-25ML - Milliliter70069-74779ad50df-fb54-4337-afd6-9163557cd80912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-747POTASSIUM PHOSPHATE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC]3Current NDC, 2 package rows20240712_52f07402-1869-4a97-9c92-9729dc611f85.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium PhosphatePOTASSIUM PHOSPHATESomerset Therapeutics, LLC52f07402-1869-4a97-9c92-9729dc611f852024-07-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217726
application number: ANDA217726
ndc (product): 70069-747

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1928567potassium phosphates (phosphorus 15 MMOL / potassium 22 MEQ) in 5 ML InjectionPSN52f07402-1869-4a97-9c92-9729dc611f853
1928569potassium phosphates (phosphorus 45 MMOL / potassium 66 MEQ) in 15 ML InjectionPSN52f07402-1869-4a97-9c92-9729dc611f853
192856915 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML InjectionSCD52f07402-1869-4a97-9c92-9729dc611f853
19285675 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML InjectionSCD52f07402-1869-4a97-9c92-9729dc611f853
192856915 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML InjectionSY52f07402-1869-4a97-9c92-9729dc611f853
192856915 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML InjectionSY52f07402-1869-4a97-9c92-9729dc611f853
19285675 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML InjectionSY52f07402-1869-4a97-9c92-9729dc611f853
19285675 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML InjectionSY52f07402-1869-4a97-9c92-9729dc611f853
1928567phosphorus 15 MMOL / potassium 22 MEQ per 5 ML InjectionSY52f07402-1869-4a97-9c92-9729dc611f853
1928569phosphorus 45 MMOL / potassium 66 MEQ per 15 ML InjectionSY52f07402-1869-4a97-9c92-9729dc611f853
1928567potassium phosphates (phosphorus 15 MMOL / potassium 22 MEQ) per 5 ML InjectionSY52f07402-1869-4a97-9c92-9729dc611f853
1928569potassium phosphates (phosphorus 45 MMOL / potassium 66 MEQ) per 15 ML InjectionSY52f07402-1869-4a97-9c92-9729dc611f853

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-747-257006907472525 BOTTLE in 1 CARTON (70069-747-25) / 15 mL in 1 BOTTLE25 bottle2024-07-11NoNoCurrent