Pentoxifylline

Product NDC: 68682-101
Requested package NDC: 68682-101-10
11-digit product format: 686820101
Labeler code: 68682
Product ID: 68682-101_67e482c0-c704-4a68-a7e5-d867fb5fc485
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pentoxifylline
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Oceanside Pharmaceuticals
Application: ANDA075028
Marketing category: ANDA
Marketing start: 2014-08-22
Marketing end: 0000-00-00
Substance: PENTOXIFYLLINE
Active strength: 400 mg/1
Pharmacologic classes: Blood Viscosity Reducer [EPC], Hematologic Activity Alteration [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68682-101	68682-101-10	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68682-101	68682-101-10	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68682-101	68682-101-10	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A075028-001	PENTOXIFYLLINE	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL			1998-07-20

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	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1998-07-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1998-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL		1998-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075028-001	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A075028-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075028-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075028-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075028-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075028-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075028-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075028-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075028-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075028-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075028-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075028-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075028-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075028-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075028-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075028-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075028-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075028-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075028-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075028-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075028-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075028-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075028-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075028-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075028-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075028-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075028-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075028-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075028-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075028-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075028-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075028-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075028-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075028-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075028-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075028-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075028-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075028-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075028-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-101-10	EA - Each	68682-101	47417c83-e890-4efb-8f95-65f2b2f17c1a	1	2014-10-03
68682-101-50	EA - Each	68682-101	9838743a-4f50-4682-beb0-fc8b06352e57	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PENTOXIFYLLINE	ACTIVE INGREDIENT	SD6QCT3TSU	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	2
PENTOXIFYLLINE	ACTIVE MOIETY	SD6QCT3TSU	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-101	PENTOXIFYLLINE TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	8	Legacy NDC	20220525_c28cf3c3-8c13-46c6-a051-6de99db19882.zip

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	73a6351c-5a8d-abbf-e053-2991aa0a5382	5
312301	pentoxifylline 400 MG Extended Release Oral Tablet	SCD	73a6351c-5a8d-abbf-e053-2991aa0a5382	5
312301	pentoxifylline 400 MG Extended Release Oral Tablet	PSN	e95e105c-d2b0-47f8-9c9c-c825d5d85578	2
312301	pentoxifylline 400 MG Extended Release Oral Tablet	SCD	e95e105c-d2b0-47f8-9c9c-c825d5d85578	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-101-10	68682010110	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-101-10)	2014-08-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PENTOXIFYLLINE Extended-Release Tablets, 400 mg	NuCare Pharmaceuticals,Inc.	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	5
PENTOXIFYLLINE Extended-Release Tablets, 400 mg	Aphena Pharma Solutions - Tennessee, LLC	2019-12-17	HUMAN PRESCRIPTION DRUG LABEL	2
PENTOXIFYLLINE Extended-Release Tablets, 400 mg	Oceanside Pharmaceuticals \| Bausch Health Companies Inc.	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	8