Didanosine

Product NDC: 65862-310
Requested package NDC: 65862-310-30
11-digit product format: 658620310
Labeler code: 65862
Product ID: 65862-310_e8187d15-dc5b-4f8f-903c-cf1733d9a135
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Didanosine
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA090094
Marketing category: ANDA
Marketing start: 2008-09-24
Marketing end: 0000-00-00
Substance: DIDANOSINE
Active strength: 125 mg/1
Pharmacologic classes: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	65862-310	65862-310-30	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A090094-001	DIDANOSINE	DIDANOSINE	125MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24
A090094-002	DIDANOSINE	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24
A090094-003	DIDANOSINE	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24
A090094-004	DIDANOSINE	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090094-001	DIDANOSINE	125MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090094-002	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090094-003	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090094-004	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090094-001	DIDANOSINE	125MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090094-002	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090094-003	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090094-004	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090094-001	DIDANOSINE	125MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090094-002	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090094-003	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090094-004	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090094-001	DIDANOSINE	125MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090094-002	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090094-003	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090094-004	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090094-001	DIDANOSINE	125MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090094-002	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090094-003	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090094-004	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090094-001	DIDANOSINE	125MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090094-002	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090094-003	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090094-004	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090094-001	DIDANOSINE	125MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090094-002	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090094-003	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090094-004	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090094-001	DIDANOSINE	125MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090094-002	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090094-003	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090094-004	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090094-001	DIDANOSINE	125MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090094-002	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090094-003	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090094-004	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090094-001	DIDANOSINE	125MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090094-002	DIDANOSINE	200MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090094-003	DIDANOSINE	250MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090094-004	DIDANOSINE	400MG	CAPSULE, DELAYED REL PELLETS / ORAL	2008-09-24	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090094-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090094-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090094-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090094-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090094-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090094-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090094-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090094-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090094-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090094-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090094-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090094-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090094-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090094-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090094-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090094-004	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-310-30	EA - Each	65862-310	13bcf933-cff5-41db-9bd1-18fbe2d8ea4e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIDANOSINE	ACTIVE INGREDIENT	K3GDH6OH08	DIDANOSINE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	8
DIDANOSINE	ACTIVE MOIETY	K3GDH6OH08	DIDANOSINE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	8
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	DIDANOSINE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	8
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	DIDANOSINE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DIDANOSINE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIDANOSINE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	8
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	DIDANOSINE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	8
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DIDANOSINE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	8
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DIDANOSINE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIDANOSINE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DIDANOSINE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DIDANOSINE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIDANOSINE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIDANOSINE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	8

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K3GDH6OH08	DIDANOSINE	69655-05-6	DIDANOSINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-310-30	65862031030	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-310-30)	2008-09-24	0000-00-00	No	No	Current