PENTOXIFYLLINE

Product NDC: 63629-2910
11-digit product format: 636292910
Labeler code: 63629
Product ID: 63629-2910_8512c162-5ecc-4d0d-a3fa-ebf950299c1c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PENTOXIFYLLINE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075191
Marketing category: ANDA
Marketing start: 1999-06-10
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
A075191-001	PENTOXIFYLLINE	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075191-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075191-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075191-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075191-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075191-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075191-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075191-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075191-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075191-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075191-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075191-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075191-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075191-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075191-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075191-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075191-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075191-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075191-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075191-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075191-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075191-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075191-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075191-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075191-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075191-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075191-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075191-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075191-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075191-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075191-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075191-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075191-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075191-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075191-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075191-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075191-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075191-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075191-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075191-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075191-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075191-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

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
84816505-9253-41cf-8894-2b2d0e4aff67	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
63629-2910-1	PENTOXIFYLLINE	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	1012
63629-2910-2	PENTOXIFYLLINE	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	1012
63629-2910-3	PENTOXIFYLLINE	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2910-1	EA - Each	63629-2910	2ee7ffea-db46-448f-b925-1d9c8421e092	1	2013-02-13
63629-2910-2	EA - Each	63629-2910	14095e7e-296f-4303-a257-ee96023379ab	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PENTOXIFYLLINE	ACTIVE INGREDIENT	SD6QCT3TSU	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
PENTOXIFYLLINE	ACTIVE MOIETY	SD6QCT3TSU	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2910	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1011	Current NDC, Legacy NDC, 3 package rows	20241220_84816505-9253-41cf-8894-2b2d0e4aff67.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
PENTOXIFYLLINE	PENTOXIFYLLINE	Major Pharmaceuticals	59c9a583-1f93-480f-879c-457a574374da	2025-09-22	Adverse reactions	Exact identifier application applno (ANDA): 075191 application number: ANDA075191
PENTOXIFYLLINE	PENTOXIFYLLINE	Bryant Ranch Prepack	84816505-9253-41cf-8894-2b2d0e4aff67	2025-09-04	Adverse reactions	Exact identifier application applno (ANDA): 075191 application number: ANDA075191 ndc (product): 63629-2910
PENTOXIFYLLINE	PENTOXIFYLLINE	Apotex Corp.	40ae2d9a-0d95-640d-0640-f76e7e1a13cb	2025-08-21	Adverse reactions	Exact identifier application applno (ANDA): 075191 application number: ANDA075191

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	84816505-9253-41cf-8894-2b2d0e4aff67	1012
312301	pentoxifylline 400 MG Extended Release Oral Tablet	SCD	84816505-9253-41cf-8894-2b2d0e4aff67	1012

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2910-1	63629291001	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2910-1)	2005-08-09	0000-00-00	No	No	Current
63629-2910-2	63629291002	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2910-2)	2024-12-06	0000-00-00	No	No	Current
63629-2910-3	63629291003	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2910-3)	2023-10-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mg Rx Only	Bryant Ranch Prepack	2025-09-04	HUMAN PRESCRIPTION DRUG LABEL	1012