Tenofovir Disoproxil Fumarate

Product NDC: 71335-3155
11-digit product format: 713353155
Labeler code: 71335
Product ID: 71335-3155_1d924bad-47a1-48dd-bf2e-5a44ebc48d60
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tenofovir Disoproxil Fumarate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA209498
Marketing category: ANDA
Marketing start: 2025-11-26
Substance: TENOFOVIR DISOPROXIL FUMARATE
Active strength: 300 mg/1
Pharmacologic classes: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209498-001	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02
A209498-002	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02
A209498-003	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A209498-001	AB
A209498-002	AB
A209498-003	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 4 · 129 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
2026-09-14 22:38:34	2026-08	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209498-002	TENOFOVIR DISOPROXIL FUMARATE	250MG	TABLET / ORAL	AB	2018-03-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209498-003	TENOFOVIR DISOPROXIL FUMARATE	300MG	TABLET / ORAL	AB	2018-03-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209498-001	TENOFOVIR DISOPROXIL FUMARATE	200MG	TABLET / ORAL	AB	2018-03-02	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209498-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209498-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209498-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209498-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209498-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209498-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209498-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209498-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209498-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209498-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209498-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209498-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209498-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209498-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209498-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209498-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209498-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209498-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209498-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209498-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209498-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209498-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209498-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209498-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209498-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209498-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209498-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209498-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209498-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209498-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209498-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209498-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209498-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209498-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209498-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209498-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209498-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209498-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209498-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209498-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Tenofovir Disoproxil Fumarate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TENOFOVIR DISOPROXIL FUMARATE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
OTT9J7900I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349251	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
e0ae0aa2-3baa-4b75-9e85-68b5338c3c14	Available on FDA.report

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	Bryant Ranch Prepack	e0ae0aa2-3baa-4b75-9e85-68b5338c3c14	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209498 application number: ANDA209498 ndc (product): 71335-3155
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	Bryant Ranch Prepack	3285f345-e58d-4831-a6a8-31094c8c546d	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209498 application number: ANDA209498
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	Florida Pharmaceutical Products, LLC.	0c7d72d6-bf80-49e0-921c-20169e87e62f	2025-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209498 application number: ANDA209498
Tenofovir Disoproxil Fumarate	TENOFOVIR DISOPROXIL FUMARATE	Quinn Pharmaceuticals	92569e53-507e-7a5b-e053-2995a90aca35	2025-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209498 application number: ANDA209498

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OTT9J7900I	TENOFOVIR DISOPROXIL FUMARATE	202138-50-9	TENOFOVIR DISOPROXIL FUMARATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-3155-1	71335315501	30 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-3155-1)	2026-07-13	No	No	Current
71335-3155-2	71335315502	15 TABLET, COATED in 1 BOTTLE, PLASTIC (71335-3155-2)	2026-07-13	No	No	Current