Application 212799

Type: ANDA
Sponsor: BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CITRATE	POTASSIUM CITRATE	TABLET, EXTENDED RELEASE;ORAL	10MEQ	No	No
002	POTASSIUM CITRATE	POTASSIUM CITRATE	TABLET, EXTENDED RELEASE;ORAL	15MEQ	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212799-001	POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB		2020-06-29
A212799-002	POTASSIUM CITRATE	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB		2020-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212799-001	AB
A212799-002	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212799-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL		2020-06-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212799-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		2020-06-29	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212799-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212799-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212799-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212799-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212799-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212799-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212799-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212799-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212799-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212799-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212799-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212799-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212799-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212799-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212799-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212799-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212799-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212799-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212799-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212799-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212799-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212799-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212799-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212799-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212799-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212799-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212799-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212799-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212799-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212799-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212799-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212799-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212799-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212799-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212799-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212799-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212799-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212799-002	AB	1	`782e0a99824c…`
2021-03-12 10:30 UTC	2021-03	A212799-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A212799-002	AB	1	`5aa47cf7b7d7…`

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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POTASSIUM CITRATE	POTASSIUM CITRATE	Rising Pharma Holdings, Inc.	164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CITRATE generic name: POTASSIUM CITRATE
Potassium Citrate	POTASSIUM CITRATE	Bryant Ranch Prepack	ff67f638-5b53-406a-962a-87773a91fc48	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: Potassium Citrate generic name: POTASSIUM CITRATE
Potassium Citrate	POTASSIUM CITRATE	REMEDYREPACK INC.	a9cc636d-3e26-450c-9df8-665d530d626f	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: Potassium Citrate generic name: POTASSIUM CITRATE
Potassium Citrate	POTASSIUM CITRATE	Bryant Ranch Prepack	6271d84e-d991-4bb8-ac9f-6d5cc879b631	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Potassium Citrate generic name: POTASSIUM CITRATE
Potassium Citrate	POTASSIUM CITRATE	Bryant Ranch Prepack	595343aa-b760-4158-9c49-dd5368f45e2c	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Potassium Citrate generic name: POTASSIUM CITRATE
Potassium Citrate	POTASSIUM CITRATE	ANI Pharmaceuticals, Inc.	2fb31727-68b1-4183-947d-00e08bf99987	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: Potassium Citrate generic name: POTASSIUM CITRATE
Potassium Citrate	POTASSIUM CITRATE	Biocomp Pharma, Inc.	b32fe71a-4a58-04a1-64d3-bc3cc4a895bf	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Potassium Citrate generic name: POTASSIUM CITRATE
Potassium Citrate	POTASSIUM CITRATE	Bryant Ranch Prepack	ebf1f1f1-4458-4d34-8432-21698a550e07	2025-11-04	Warnings, Adverse reactions	Name fallback brand name: Potassium Citrate generic name: POTASSIUM CITRATE
POTASSIUM CITRATE EXTENDED RELEASE	POTASSIUM CITRATE	Bryant Ranch Prepack	3dd9c9eb-df19-4ec9-bc77-f3a159b33d94	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CITRATE
POTASSIUM CITRATE	POTASSIUM CITRATE	Bryant Ranch Prepack	b3ccba22-48cd-45f8-8c72-b80f34fe56be	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CITRATE generic name: POTASSIUM CITRATE
POTASSIUM CITRATE	POTASSIUM CITRATE	REMEDYREPACK INC.	08c769d4-1dc0-4130-8f9c-cddace13a79b	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CITRATE generic name: POTASSIUM CITRATE
POTASSIUM CITRATE EXTENDED RELEASE	POTASSIUM CITRATE	Bryant Ranch Prepack	44ab2c4f-4a76-470d-98fb-8874c692a967	2025-08-20	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CITRATE
Potassium Citrate	POTASSIUM CITRATE	Upsher-Smith Laboratories, LLC	2215dc1d-0b5a-469e-9b51-4d7480a51078	2025-07-14	Warnings, Adverse reactions	Name fallback brand name: Potassium Citrate generic name: POTASSIUM CITRATE
POTASSIUM CITRATE EXTENDED RELEASE	POTASSIUM CITRATE	Strides Pharma Inc.	5f38b02c-703c-4fc2-b833-654e41bd617f	2025-07-01	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CITRATE
POTASSIUM CITRATE EXTENDED RELEASE	POTASSIUM CITRATE	Bryant Ranch Prepack	8f5f7078-3c2d-406f-9222-b82a0f79d168	2025-05-02	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CITRATE
POTASSIUM CITRATE EXTENDED RELEASE	POTASSIUM CITRATE	Bryant Ranch Prepack	b6ce81aa-ed9e-4eac-9f9c-26e2560f06db	2025-05-02	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CITRATE
POTASSIUM CITRATE	POTASSIUM CITRATE	Bryant Ranch Prepack	012c925e-5874-472b-a675-00bf79f64980	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CITRATE generic name: POTASSIUM CITRATE
Potassium Citrate	POTASSIUM CITRATE	American Health Packaging	1201c777-2388-4235-bb8f-eb7dc1e867f8	2024-09-03	Warnings, Adverse reactions	Name fallback brand name: Potassium Citrate generic name: POTASSIUM CITRATE
Potassium Citrate	POTASSIUM CITRATE	Bryant Ranch Prepack	f2ab3c2e-2a6e-4698-afad-260bdf0d259e	2024-08-06	Warnings, Adverse reactions	Name fallback brand name: Potassium Citrate generic name: POTASSIUM CITRATE
POTASSIUM CITRATE EXTENDED RELEASE	POTASSIUM CITRATE	Bryant Ranch Prepack	9774b7c5-4695-47c9-9eb8-e0af2e05f5c3	2024-05-20	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CITRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69452-193	Potassium Citrate	Potassium Citrate	Bionpharma Inc.	ANDA	Current
69452-193	Potassium Citrate	Potassium Citrate	Bionpharma Inc.	ANDA	Current
69452-194	Potassium Citrate	Potassium Citrate	Bionpharma Inc.	ANDA	Current
69452-194	Potassium Citrate	Potassium Citrate	Bionpharma Inc.	ANDA	Current