PENTOXIFYLLINE

Product NDC: 0904-5448
Requested package NDC: 0904-5448-61
11-digit product format: 009045448
Labeler code: 0904
Product ID: 0904-5448_e41391a6-e956-41ab-8169-45f6e48d4fa2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PENTOXIFYLLINE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Major Pharmaceuticals
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 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
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 · 41 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
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075191-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	1999-06-09	`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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075191-001	AB	1	`cb3db0bc1861…`

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
59c9a583-1f93-480f-879c-457a574374da	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	Strength	SPL version
0904-5448-61	PENTOXIFYLLINE	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1		6
0904-5448-61	PENTOXIFYLLINE	100 in 1 CARTON	TABLET, EXTENDED RELEASE	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5448-61	EA - Each	0904-5448	1e1b15c2-48e7-4f5b-bbcb-a24c29d9a524	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 [MAJOR PHARMACEUTICALS]	1
PENTOXIFYLLINE	ACTIVE MOIETY	SD6QCT3TSU	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-5448	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 2 package rows	20241030_59c9a583-1f93-480f-879c-457a574374da.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 ndc (package): 0904-5448-61 ndc (product): 0904-5448 ndc11 (package): 00904544861
PENTOXIFYLLINE	PENTOXIFYLLINE	Bryant Ranch Prepack	84816505-9253-41cf-8894-2b2d0e4aff67	2025-09-04	Adverse reactions	Exact identifier application applno (ANDA): 075191 application number: ANDA075191
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	59c9a583-1f93-480f-879c-457a574374da	6
312301	pentoxifylline 400 MG Extended Release Oral Tablet	SCD	59c9a583-1f93-480f-879c-457a574374da	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5448-61	00904544861	100 BLISTER PACK in 1 CARTON (0904-5448-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	100 blister pack	1999-06-10	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	Major Pharmaceuticals	2025-09-22	HUMAN PRESCRIPTION DRUG LABEL	6