FDA.reportPublic FDA data

POTASSIUM PHOSPHATES

Product NDC
65145-194
11-digit product format
651450194
Labeler code
65145
Product ID
65145-194_e6c7b072-db35-42c2-9bc2-d25cd20ca8b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM PHOSPHATES
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA220373
Marketing category
ANDA
Marketing start
2026-09-17
Substance
POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC
Active strength
224; 236 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
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220373-001POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2026-03-12
A220373-002POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2026-03-12
A220373-003POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2026-03-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A220373-001AP
A220373-002AP
A220373-003AP

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
2026-09-14 22:38:342026-08A220373-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2026-03-1284e616aacf4f…
2026-09-14 22:38:342026-08A220373-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2026-03-1284e616aacf4f…
2026-09-14 22:38:342026-08A220373-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2026-03-1284e616aacf4f…
2026-08-18 06:07:402026-07A220373-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2026-03-12caaa826d4ba7…
2026-08-18 06:07:402026-07A220373-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2026-03-12caaa826d4ba7…
2026-08-18 06:07:402026-07A220373-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2026-03-12caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220373-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2026-03-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220373-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2026-03-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220373-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2026-03-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A220373-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A220373-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A220373-003AP184e616aacf4f…
2026-08-18 06:07:402026-07A220373-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A220373-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A220373-003AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220373-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220373-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220373-003AP1a50c72e98297…

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
POTASSIUM PHOSPHATES
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM PHOSPHATE, MONOBASIC224 mg/mL
POTASSIUM PHOSPHATE, DIBASIC236 mg/mL

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
65145-194-01POTASSIUM PHOSPHATES5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE51
65145-194-25POTASSIUM PHOSPHATES25 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE251

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 PHOSPHATESPOTASSIUM PHOSPHATESGLENMARK PHARMACEUTICALS INC., USA70c7710c-a354-4941-bd46-e64d6ea6b5dc2026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220373
application number: ANDA220373

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1928567potassium phosphates (phosphorus 15 MMOL / potassium 22 MEQ) in 5 ML InjectionPSNfbbd8380-9848-4862-8c73-2f53fcdf71201
2667657potassium phosphates (phosphorus 3 MMOL / potassium 4.4 MEQ) in 1 ML Injectable SolutionPSNfbbd8380-9848-4862-8c73-2f53fcdf71201
1928569potassium phosphates (phosphorus 45 MMOL / potassium 66 MEQ) in 15 ML InjectionPSNfbbd8380-9848-4862-8c73-2f53fcdf71201
192856915 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML InjectionSCDfbbd8380-9848-4862-8c73-2f53fcdf71201
19285675 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML InjectionSCDfbbd8380-9848-4862-8c73-2f53fcdf71201
2667657dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML Injectable SolutionSCDfbbd8380-9848-4862-8c73-2f53fcdf71201
192856915 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
192856915 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
19285675 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
19285675 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
2667657dibasic K+ phosphate 236 MG/ML / monobasic K+ phosphate 224 MG/ML Injectable SolutionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
2667657dibasic Pot phosphate 236 MG/ML / monobasic Pot phosphate 224 MG/ML Injectable SolutionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
1928567phosphorus 15 MMOL / potassium 22 MEQ per 5 ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
2667657phosphorus 3 MMOL / potassium 4.4 MEQ per 1 ML Injectable SolutionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
1928569phosphorus 45 MMOL / potassium 66 MEQ per 15 ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
1928567potassium phosphates (phosphorus 15 MMOL / potassium 22 MEQ) per 5 ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
1928569potassium phosphates (phosphorus 45 MMOL / potassium 66 MEQ) per 15 ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1928567potassium phosphates (phosphorus 15 MMOL / potassium 22 MEQ) in 5 ML InjectionPSNfbbd8380-9848-4862-8c73-2f53fcdf71201
2667657potassium phosphates (phosphorus 3 MMOL / potassium 4.4 MEQ) in 1 ML Injectable SolutionPSNfbbd8380-9848-4862-8c73-2f53fcdf71201
1928569potassium phosphates (phosphorus 45 MMOL / potassium 66 MEQ) in 15 ML InjectionPSNfbbd8380-9848-4862-8c73-2f53fcdf71201
192856915 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML InjectionSCDfbbd8380-9848-4862-8c73-2f53fcdf71201
19285675 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML InjectionSCDfbbd8380-9848-4862-8c73-2f53fcdf71201
2667657dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML Injectable SolutionSCDfbbd8380-9848-4862-8c73-2f53fcdf71201
192856915 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
192856915 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
19285675 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
19285675 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
2667657dibasic K+ phosphate 236 MG/ML / monobasic K+ phosphate 224 MG/ML Injectable SolutionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
2667657dibasic Pot phosphate 236 MG/ML / monobasic Pot phosphate 224 MG/ML Injectable SolutionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
1928567phosphorus 15 MMOL / potassium 22 MEQ per 5 ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
2667657phosphorus 3 MMOL / potassium 4.4 MEQ per 1 ML Injectable SolutionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
1928569phosphorus 45 MMOL / potassium 66 MEQ per 15 ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
1928567potassium phosphates (phosphorus 15 MMOL / potassium 22 MEQ) per 5 ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201
1928569potassium phosphates (phosphorus 45 MMOL / potassium 66 MEQ) per 15 ML InjectionSYfbbd8380-9848-4862-8c73-2f53fcdf71201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-194-01651450194015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
65145-194-256514501942525 VIAL, SINGLE-DOSE in 1 CARTON (65145-194-25) / 5 mL in 1 VIAL, SINGLE-DOSE (65145-194-01) 2026-09-17NoNoCurrent