FDA.reportPublic FDA data

POTASSIUM PHOSPHATES

Product NDC
80830-1691
Requested package NDC
80830-1691-7
11-digit product format
808301691
Labeler code
80830
Product ID
80830-1691_88f63f92-ae9a-4c19-a47e-2cbcab786cc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
potassium phosphate, monobasic potassium phosphate, dibasic injection,
Dosage form
SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals Private Limited
Application
ANDA216344
Marketing category
ANDA
Marketing start
2025-07-09
Substance
POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
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
2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216344-001POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-10
A216344-002POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-10
A216344-003POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216344-001AP
A216344-002AP
A216344-003AP

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
2026-08-01 22:54:322026-06A216344-001POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-10a50c72e98297…
2026-08-01 22:54:322026-06A216344-002POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-10a50c72e98297…
2026-08-01 22:54:322026-06A216344-003POTASSIUM PHOSPHATES11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)SOLUTION / INTRAVENOUSAP2023-10-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216344-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A216344-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A216344-003AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited125121b8-bc4c-44ee-906e-e72f652a5aa62025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216344
application number: ANDA216344
ndc (product): 80830-1691
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited98315c6e-308d-423b-a046-4be1f54d30ae2025-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216344
application number: ANDA216344
ndc (package): 80830-1691-7
ndc (product): 80830-1691
ndc11 (package): 80830169107
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited89136c51-a60b-4269-bd05-9489f060a7342024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216344
application number: ANDA216344
ndc (product): 80830-1691

Additional Listing Data#

Finished product
Yes
Brand name base
POTASSIUM PHOSPHATES
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM PHOSPHATE, MONOBASIC236 mg/mL
POTASSIUM PHOSPHATE, DIBASIC224 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
98315c6e-308d-423b-a046-4be1f54d30aeAvailable 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
80830-1691-1POTASSIUM PHOSPHATES15 mL in 1 VIAL, SINGLE-DOSESOLUTION, CONCENTRATE159
80830-1691-2POTASSIUM PHOSPHATES10 in 1 CARTONSOLUTION, CONCENTRATE109
80830-1691-5POTASSIUM PHOSPHATES25 in 1 CARTONSOLUTION, CONCENTRATE259
80830-1691-3POTASSIUM PHOSPHATES15 mL in 1 VIAL, SINGLE-DOSESOLUTION, CONCENTRATE151
80830-1691-6POTASSIUM PHOSPHATES15 mL in 1 VIAL, SINGLE-DOSESOLUTION, CONCENTRATE151
80830-1691-7POTASSIUM PHOSPHATES10 in 1 CARTONSOLUTION, CONCENTRATE101
80830-1691-9POTASSIUM PHOSPHATES10 in 1 CARTONSOLUTION, CONCENTRATE101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80830-1691-1ML - Milliliter80830-1691eb311358-c9e8-45ba-b950-8bfe75b4fd8312023-12-05
80830-1691-2ML - Milliliter80830-16915a4c48ea-de13-4cdf-a26d-dbd82861809e12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80830-1691POTASSIUM PHOSPHATES (POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,) SOLUTION, CONCENTRATE [AMNEAL PHARMACEUTICALS PRIVATE LIMITED]9Current NDC, 3 package rows20250108_89136c51-a60b-4269-bd05-9489f060a734.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1928567potassium phosphates (phosphorus 15 MMOL / potassium 22 MEQ) in 5 ML InjectionPSN89136c51-a60b-4269-bd05-9489f060a7349
1928570potassium phosphates (phosphorus 150 MMOL / potassium 220 MEQ) in 50 ML InjectionPSN89136c51-a60b-4269-bd05-9489f060a7349
1928569potassium phosphates (phosphorus 45 MMOL / potassium 66 MEQ) in 15 ML InjectionPSN89136c51-a60b-4269-bd05-9489f060a7349
192856915 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML InjectionSCD89136c51-a60b-4269-bd05-9489f060a7349
19285675 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML InjectionSCD89136c51-a60b-4269-bd05-9489f060a7349
192857050 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML InjectionSCD89136c51-a60b-4269-bd05-9489f060a7349
192856915 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
192856915 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
19285675 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
19285675 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
192857050 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
192857050 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
1928567phosphorus 15 MMOL / potassium 22 MEQ per 5 ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
1928570phosphorus 150 MMOL / potassium 220 MEQ per 50 ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
1928569phosphorus 45 MMOL / potassium 66 MEQ per 15 ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
1928567potassium phosphates (phosphorus 15 MMOL / potassium 22 MEQ) per 5 ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
1928570potassium phosphates (phosphorus 150 MMOL / potassium 220 MEQ) per 50 ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
1928569potassium phosphates (phosphorus 45 MMOL / potassium 66 MEQ) per 15 ML InjectionSY89136c51-a60b-4269-bd05-9489f060a7349
1928569potassium phosphates (phosphorus 45 MMOL / potassium 66 MEQ) in 15 ML InjectionPSN125121b8-bc4c-44ee-906e-e72f652a5aa61
1928569potassium phosphates (phosphorus 45 MMOL / potassium 66 MEQ) in 15 ML InjectionPSN98315c6e-308d-423b-a046-4be1f54d30ae1
192856915 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML InjectionSCD98315c6e-308d-423b-a046-4be1f54d30ae1
192856915 ML dibasic potassium phosphate 236 MG/ML / monobasic potassium phosphate 224 MG/ML InjectionSCD125121b8-bc4c-44ee-906e-e72f652a5aa61
192856915 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML InjectionSY98315c6e-308d-423b-a046-4be1f54d30ae1
192856915 ML Dibasic K+ phosphate 236 MG/ML / Monobasic K+ phosphate 224 MG/ML InjectionSY125121b8-bc4c-44ee-906e-e72f652a5aa61
192856915 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML InjectionSY125121b8-bc4c-44ee-906e-e72f652a5aa61
192856915 ML Dibasic Pot phosphate 236 MG/ML / Monobasic Pot phosphate 224 MG/ML InjectionSY98315c6e-308d-423b-a046-4be1f54d30ae1
1928569phosphorus 45 MMOL / potassium 66 MEQ per 15 ML InjectionSY98315c6e-308d-423b-a046-4be1f54d30ae1
1928569phosphorus 45 MMOL / potassium 66 MEQ per 15 ML InjectionSY125121b8-bc4c-44ee-906e-e72f652a5aa61
1928569potassium phosphates (phosphorus 45 MMOL / potassium 66 MEQ) per 15 ML InjectionSY125121b8-bc4c-44ee-906e-e72f652a5aa61
1928569potassium phosphates (phosphorus 45 MMOL / potassium 66 MEQ) per 15 ML InjectionSY98315c6e-308d-423b-a046-4be1f54d30ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80830-1691-78083016910710 VIAL, SINGLE-DOSE in 1 CARTON (80830-1691-7) / 15 mL in 1 VIAL, SINGLE-DOSE (80830-1691-6) 2025-07-09NoNoCurrent