Balsalazide Disodium

Product NDC: 72789-149
11-digit product format: 727890149
Labeler code: 72789
Product ID: 72789-149_40a76214-2087-acc4-e063-6394a90ae00e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Balsalazide Disodium
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA077806
Marketing category: ANDA
Marketing start: 2007-12-28
Substance: BALSALAZIDE DISODIUM
Active strength: 750 mg/1
Pharmacologic classes: Aminosalicylate [EPC], Aminosalicylic Acids [CS]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077806-001	BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB		2007-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077806-001	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 · 41 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	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077806-001	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	2007-12-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A077806-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077806-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077806-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077806-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077806-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077806-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077806-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077806-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077806-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077806-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077806-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077806-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077806-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077806-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077806-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077806-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077806-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077806-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077806-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077806-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077806-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077806-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077806-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077806-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077806-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077806-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077806-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077806-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077806-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077806-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077806-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077806-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077806-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077806-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077806-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077806-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077806-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077806-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077806-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077806-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Balsalazide Disodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BALSALAZIDE DISODIUM	750 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1XL6BJI034	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
885857	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b3ecc533-dd55-4a2f-84c4-ecd454aae766	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8e3d9cc4-ed07-08af-508a-5f750e6cdb51	Product name	3	20260112
34627c48-41a0-6950-dec1-e0baf87a4e18	Product name	2	20150914

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72789-149-69	Balsalazide Disodium	280 in 1 BOTTLE, PLASTIC	CAPSULE	280		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-149-69	EA - Each	72789-149	ef1bca9c-0e01-416f-9719-bb3ca76f2297	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-149	BALSALAZIDE DISODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]	15	Current NDC, Legacy NDC, 1 package rows	20240719_b3ecc533-dd55-4a2f-84c4-ecd454aae766.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Balsalazide Disodium	BALSALAZIDE DISODIUM	PD-Rx Pharmaceuticals, Inc.	b3ecc533-dd55-4a2f-84c4-ecd454aae766	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077806 application number: ANDA077806 ndc (product): 72789-149
Balsalazide Disodium	BALSALAZIDE DISODIUM	Golden State Medical Supply, Inc.	029833fa-ec5c-6a39-e063-6294a90aa063	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077806 application number: ANDA077806
Balsalazide Disodium	BALSALAZIDE DISODIUM	Hikma Pharmaceuticals USA Inc.	a0498308-14b2-4456-8e13-795f6fc8ea30	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077806 application number: ANDA077806

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1XL6BJI034	BALSALAZIDE DISODIUM	150399-21-6	BALSALAZIDE DISODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
885857	balsalazide disodium 750 MG Oral Capsule	PSN	b3ecc533-dd55-4a2f-84c4-ecd454aae766	16
885857	balsalazide disodium 750 MG Oral Capsule	SCD	b3ecc533-dd55-4a2f-84c4-ecd454aae766	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-149-69	72789014969	280 CAPSULE in 1 BOTTLE, PLASTIC (72789-149-69)	280 capsule	2020-12-02	0000-00-00	No	No	Current