Monobasic Sodium Phosphate and Dibasic Sodium Phosphate

Product NDC: 43386-030
11-digit product format: 433860030
Labeler code: 43386
Product ID: 43386-030_a1083256-d69a-4ff6-be4e-9719451792ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Monobasic Sodium Phosphate and Dibasic Sodium Phosphate
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals,Inc.
Application: ANDA079247
Marketing category: ANDA
Marketing start: 2012-01-20
Substance: SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
Active strength: 1.105; .398 g/1; g/1
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]
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 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
A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL	AB		2011-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL	AB		2011-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL	AB		2011-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL			2011-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL	AB		2011-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL	AB		2011-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL	AB		2011-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL	AB		2011-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL			2011-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL			2011-12-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL			2011-12-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL			2011-12-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL			2011-12-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL		RS	2011-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL	AB		2011-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL	AB		2011-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL	AB		2011-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL	AB		2011-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL	AB		2011-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079247-001	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	0.398GM;1.102GM	TABLET / ORAL	AB		2011-12-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079247-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079247-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079247-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A079247-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079247-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079247-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079247-001	AB	1	`5aa47cf7b7d7…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079247-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079247-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079247-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079247-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079247-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079247-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079247-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079247-001	AB	1	`cb3db0bc1861…`

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: Monobasic Sodium Phosphate and Dibasic Sodium Phosphate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	1.105 g/1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	.398 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
593YOG76RN	Internal UNII lookup
22ADO53M6F	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e2fcc382-6fac-4438-ad02-ebc8528dd59a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43386-030-01	2023-02-07	C162847	48780-1	f386c64a-23d7-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE TABLETS safely and effectively. See full prescribing information for MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE TABLETS Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, for oral use Initial U.S. Approval:2006
43386-030-01	2023-01-30	C162847	48780-1	f386c64a-23d7-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE TABLETS safely and effectively. See full prescribing information for MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE TABLETS Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets, for oral use Initial U.S. Approval:2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43386-030-01	Monobasic Sodium Phosphate and Dibasic Sodium Phosphate	100 in 1 BOTTLE	TABLET	100		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-030	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE TABLET [LUPIN PHARMACEUTICALS,INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240131_e2fcc382-6fac-4438-ad02-ebc8528dd59a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Monobasic Sodium Phosphate and Dibasic Sodium Phosphate	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE	Lupin Pharmaceuticals,Inc.	e2fcc382-6fac-4438-ad02-ebc8528dd59a	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079247 application number: ANDA079247 ndc (product): 43386-030

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
593YOG76RN	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	10049-21-5	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
22ADO53M6F	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	7558-79-4	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-030-01	43386003001	100 TABLET in 1 BOTTLE (43386-030-01)	100 tablet	2012-01-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Monobasic Sodium Phosphate and Dibasic Sodium Phosphate	Lupin Pharmaceuticals,Inc. \| Novel Laboratories, Inc.	2024-01-30	HUMAN PRESCRIPTION DRUG LABEL	5