Pentoxifylline

Product NDC: 16571-856
11-digit product format: 165710856
Labeler code: 16571
Product ID: 16571-856_06c53ec5-f3d9-47e2-943e-631ed695adcc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pentoxifylline
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA074425
Marketing category: ANDA
Marketing start: 2024-06-11
Substance: PENTOXIFYLLINE
Active strength: 400 mg/1
Pharmacologic classes: Blood Viscosity Reducer [EPC], Hematologic Activity Alteration [PE]
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 42.

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
A074425-001	PENTOXIFYLLINE	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		1997-07-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074425-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1997-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074425-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1997-07-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074425-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074425-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074425-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074425-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074425-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074425-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074425-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074425-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074425-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074425-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074425-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074425-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074425-001	AB	1	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074425-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pentoxifylline
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PENTOXIFYLLINE	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SD6QCT3TSU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312301	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
cd840a2c-2a0e-4b2b-84ff-a0406bb6fa37	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
06331747-0b00-4cea-707f-3d3bfb5d208d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16571-856-01	Pentoxifylline	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	3
16571-856-50	Pentoxifylline	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	3
16571-856-90	Pentoxifylline	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	3
16571-856-90	Pentoxifylline	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-856-01	EA - Each	16571-856	61d08ea3-785d-4054-a598-65c771db9ef6	1	2024-08-12
16571-856-50	EA - Each	16571-856	4af7d484-43b2-4ca9-a45e-d27d83cd21f9	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-856	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]	3	Current NDC, 4 package rows	20250426_cd840a2c-2a0e-4b2b-84ff-a0406bb6fa37.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pentoxifylline	PENTOXIFYLLINE	Rising Pharma Holdings, Inc.	cd840a2c-2a0e-4b2b-84ff-a0406bb6fa37	2026-05-15	Adverse reactions	Exact identifier application applno (ANDA): 074425 application number: ANDA074425 ndc (product): 16571-856
Pentoxifylline	PENTOXIFYLLINE	Bryant Ranch Prepack	c3ad4fb4-8995-46ab-86e9-7ec67ef607f9	2025-04-07	Adverse reactions	Exact identifier application applno (ANDA): 074425 application number: ANDA074425

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SD6QCT3TSU	PENTOXIFYLLINE	6493-05-6	PENTOXIFYLLINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312301	pentoxifylline 400 MG Extended Release Oral Tablet	PSN	cd840a2c-2a0e-4b2b-84ff-a0406bb6fa37	3
312301	pentoxifylline 400 MG Extended Release Oral Tablet	SCD	cd840a2c-2a0e-4b2b-84ff-a0406bb6fa37	3
312301	pentoxifylline 400 MG Extended Release Oral Tablet	PSN	c3ad4fb4-8995-46ab-86e9-7ec67ef607f9	1
312301	pentoxifylline 400 MG Extended Release Oral Tablet	SCD	c3ad4fb4-8995-46ab-86e9-7ec67ef607f9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
16571-856-01	16571085601	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-856-01)		2024-06-11	No	No	Current
16571-856-05	16571085605	50 BLISTER PACK in 1 CARTON (16571-856-05) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	50 blister pack	2026-06-05	0		Current
16571-856-11	16571085611	10 BLISTER PACK in 1 CARTON (16571-856-11) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	10 blister pack	2026-06-05	0		Current
16571-856-50	16571085650	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-856-50)		2024-06-11	No	No	Current
16571-856-90	16571085690	1 BLISTER PACK in 1 CARTON (16571-856-90) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2024-06-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mg Rx Only	Rising Pharma Holdings, Inc. \| Unique Pharmaceutical Laboratories	2026-05-15	HUMAN PRESCRIPTION DRUG LABEL	4
PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mg Rx Only	Bryant Ranch Prepack	2025-04-07	HUMAN PRESCRIPTION DRUG LABEL	1