FDA.reportPublic FDA data

POTASSIUM CHLORIDE EXTENDED RELEASE

Product NDC
70010-021
Requested package NDC
70010-021-01
11-digit product format
700100021
Labeler code
70010
Product ID
70010-021_f33d5a34-e5e7-a85f-e053-2995a90a6db3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM CHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA211797
Marketing category
ANDA
Marketing start
2020-10-22
Substance
POTASSIUM CHLORIDE
Active strength
600 mg/1
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], 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
A211797-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04
A211797-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211797-001AB2
A211797-002AB2

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 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-044b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04782e0a99824c…
2021-12-28 21:50 UTC2021-12A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211797-001POTASSIUM CHLORIDE8MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-0487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211797-002POTASSIUM CHLORIDE10MEQTABLET, EXTENDED RELEASE / ORALAB22020-03-0487673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211797-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211797-002AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211797-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211797-002AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211797-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211797-002AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211797-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211797-002AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211797-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211797-002AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211797-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211797-002AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211797-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211797-002AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211797-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211797-002AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211797-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211797-002AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211797-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A211797-002AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211797-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211797-002AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211797-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211797-002AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211797-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211797-002AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211797-001AB218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211797-002AB218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211797-001AB215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211797-002AB215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211797-001AB215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211797-002AB215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211797-001AB214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211797-002AB214b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211797-001AB21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211797-002AB21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211797-001AB21782e0a99824c…
2021-12-28 21:50 UTC2021-12A211797-002AB21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211797-001AB2187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211797-002AB2187673890dc5c…

Additional Listing Data#

Finished product
Yes
Brand name base
POTASSIUM CHLORIDE EXTENDED RELEASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
660YQ98I10Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312529Internal RxNorm lookup
628953Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9f8d2886-9ecd-4cbf-a84a-2d221cb3497cAvailable 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
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
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
70010-021-01POTASSIUM CHLORIDE EXTENDED RELEASE100 in 1 BOTTLETABLET, EXTENDED RELEASE10010
70010-021-05POTASSIUM CHLORIDE EXTENDED RELEASE500 in 1 BOTTLETABLET, EXTENDED RELEASE50010
70010-021-10POTASSIUM CHLORIDE EXTENDED RELEASE1000 in 1 BOTTLETABLET, EXTENDED RELEASE100010
70010-021-61POTASSIUM CHLORIDE EXTENDED RELEASE3 in 1 CARTONTABLET, EXTENDED RELEASE310
70010-021-61POTASSIUM CHLORIDE EXTENDED RELEASE10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1010
70010-021-62POTASSIUM CHLORIDE EXTENDED RELEASE10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1010
70010-021-62POTASSIUM CHLORIDE EXTENDED RELEASE10 in 1 CARTONTABLET, EXTENDED RELEASE1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-021POTASSIUM CHLORIDE EXTENDED RELEASE (POTASSIUM CHLORIDE) TABLET, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 7 package rows20230129_9f8d2886-9ecd-4cbf-a84a-2d221cb3497c.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDEREMEDYREPACK INC.d1e55181-6f85-42c9-922c-808494b6399a2025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211797
application number: ANDA211797
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC3b403d60-4246-d765-e063-6394a90a12e82025-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211797
application number: ANDA211797
POTASSIUM CHLORIDE EXTENDED RELEASEPOTASSIUM CHLORIDEGranules Pharmaceuticals Inc.9f8d2886-9ecd-4cbf-a84a-2d221cb3497c2023-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211797
application number: ANDA211797
ndc (package): 70010-021-01
ndc (product): 70010-021
ndc11 (package): 70010002101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN9f8d2886-9ecd-4cbf-a84a-2d221cb3497c10
312529potassium chloride 8 MEQ (600 MG) Extended Release Oral TabletPSN9f8d2886-9ecd-4cbf-a84a-2d221cb3497c10
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD9f8d2886-9ecd-4cbf-a84a-2d221cb3497c10
312529potassium chloride 8 MEQ Extended Release Oral TabletSCD9f8d2886-9ecd-4cbf-a84a-2d221cb3497c10
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY9f8d2886-9ecd-4cbf-a84a-2d221cb3497c10
312529K+ Chloride 8 MEQ Extended Release Oral TabletSY9f8d2886-9ecd-4cbf-a84a-2d221cb3497c10
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY9f8d2886-9ecd-4cbf-a84a-2d221cb3497c10
312529Pot Chloride 8 MEQ Extended Release Oral TabletSY9f8d2886-9ecd-4cbf-a84a-2d221cb3497c10
312529potassium chloride 600 MG Extended Release Oral TabletSY9f8d2886-9ecd-4cbf-a84a-2d221cb3497c10
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY9f8d2886-9ecd-4cbf-a84a-2d221cb3497c10
628953potassium chloride 750 MG Extended Release Oral TabletSY9f8d2886-9ecd-4cbf-a84a-2d221cb3497c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70010-021-0170010002101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-021-01) 2020-10-220000-00-00NoNoCurrent