SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID

Product NDC: 31722-874
Requested package NDC: 31722-874-16
11-digit product format: 317220874
Labeler code: 31722
Product ID: 31722-874_e5f24116-74a6-1eb8-e053-2a95a90a28cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
Dosage form: POWDER, METERED
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA212789
Marketing category: ANDA
Marketing start: 2022-07-18
Marketing end: 0000-00-00
Substance: ANHYDROUS CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
Active strength: 12 g/16.1g; g/16.1g; mg/16.1g
Pharmacologic classes: Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	31722-874	31722-874-16	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL		RS	2022-07-18

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212789-001	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	12GM/PACKET;3.5GM/PACKET;10MG/PACKET	FOR SOLUTION / ORAL	RS	2022-07-18	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
31722-874-16	2025-01-30	C162847	48780-1	2cef2736-b2bd-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID FOR ORAL SOLUTION safely and effectively. See full prescribing information for SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID FOR ORAL SOLUTION. SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID for oral solution Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
31722-874-16	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	16.1 g in 1 PACKET	POWDER, METERED	16.1		1
31722-874-16	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	2 in 1 CARTON	POWDER, METERED	2		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-874	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID (SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID) POWDER, METERED [CAMBER PHARMACEUTICALS, INC.]	1	Legacy NDC, 2 package rows	20220812_b759dc12-2dc1-4ef4-a375-1a61630d54d6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XF417D3PSL	ANHYDROUS CITRIC ACID	77-92-9	ANHYDROUS CITRIC ACID
3A3U0GI71G	MAGNESIUM OXIDE	1309-48-4	MAGNESIUM OXIDE
LR57574HN8	SODIUM PICOSULFATE	1307301-38-7	SODIUM PICOSULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1305808	sodium picosulfate 10 MG / magnesium oxide 3.5 GM / citric acid 12 GM Powder for Oral Solution	PSN	b759dc12-2dc1-4ef4-a375-1a61630d54d6	1
1305808	citric acid 12000 MG / magnesium oxide 3500 MG / picosulfate sodium 10 MG Powder for Oral Solution	SCD	b759dc12-2dc1-4ef4-a375-1a61630d54d6	1
1305808	citric acid 12 GM / magnesium oxide 3.5 GM / picosulfate sodium 10 MG Powder for Oral Solution	SY	b759dc12-2dc1-4ef4-a375-1a61630d54d6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-874-16	31722087416	2 PACKET in 1 CARTON (31722-874-16) > 16.1 g in 1 PACKET	2 packet	2022-07-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	Camber Pharmaceuticals, Inc. \| Annora Pharma Private Limited	2022-08-11	HUMAN PRESCRIPTION DRUG LABEL	1