Darunavir Tablets

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-04-29
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 21:02:45

Label at a glance#

ProductDarunavir

Active ingredientDARUNAVIR

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1745-6

Darunavir tablets, 600 mg

60 Tablets

Rx only

NDC 70771-1746-3

Darunavir tablets, 800 mg

30 Tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
670026	darunavir 600 MG Oral Tablet	PSN	1
1359269	darunavir 800 MG Oral Tablet	PSN	1
670026	darunavir 600 MG Oral Tablet	SCD	1
1359269	darunavir 800 MG Oral Tablet	SCD	1
670026	darunavir (as darunavir ethanolate) 600 MG Oral Tablet	SY	1
1359269	darunavir (as darunavir ethanolate) 800 MG Oral Tablet	SY	1
670026	darunavir (as darunavir hydrate) 600 MG Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DARUNAVIR Pharmacologic Class Indexing	5	Indexing - Pharmacologic Class	20220805

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
81157882-d7f5-4b49-9a52-b2a0c7e54020	Product name	2	20260107
12fd8c59-0b3a-2882-9cdb-92782ec03e2f	Product name	6	20251113
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7	Product name	1	20180911

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1745-5	Darunavir	500 in 1 BOTTLE	TABLET, FILM COATED	500	1
70771-1745-6	Darunavir	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
70771-1745-8	Darunavir	180 in 1 BOTTLE	TABLET, FILM COATED	180	1
70771-1746-3	Darunavir	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
70771-1746-5	Darunavir	500 in 1 BOTTLE	TABLET, FILM COATED	500	1
70771-1746-9	Darunavir	90 in 1 BOTTLE	TABLET, FILM COATED	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1745	DARUNAVIR TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	1	Current NDC, 3 package rows	20240501_6a029063-b14c-4eee-9958-0d9eecb27726.zip
70771-1746	DARUNAVIR TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	1	Current NDC, 3 package rows	20240501_6a029063-b14c-4eee-9958-0d9eecb27726.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Darunavir
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1745	70771-1745-6, 70771-1745-8, 70771-1745-5
70771-1746	70771-1746-3, 70771-1746-9, 70771-1746-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DARUNAVIR	YO603Y8113	ACTIB
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED	9XZ8H6N6OH	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
DARUNAVIR	YO603Y8113	ACTIB
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED	9XZ8H6N6OH	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214085-001	DARUNAVIR	DARUNAVIR	600MG	TABLET / ORAL	AB		2023-12-13
A214085-002	DARUNAVIR	DARUNAVIR	800MG	TABLET / ORAL	AB		2023-12-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214085-001	AB
A214085-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214085-001	DARUNAVIR	600MG	TABLET / ORAL	AB	2023-12-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214085-002	DARUNAVIR	800MG	TABLET / ORAL	AB	2023-12-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A214085-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214085-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214085-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214085-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214085-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214085-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214085-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214085-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214085-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214085-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214085-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214085-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214085-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214085-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214085-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214085-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214085-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214085-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214085-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214085-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214085-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214085-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214085-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214085-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214085-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214085-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214085-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214085-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214085-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214085-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214085-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214085-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214085-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214085-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214085-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214085-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214085-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214085-002	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214085-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214085-002	AB	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Darunavir	DARUNAVIR	Zydus Lifesciences Limited	6a029063-b14c-4eee-9958-0d9eecb27726	2024-04-29		Exact identifier ndc (package): 70771-1745-8 ndc (package): 70771-1745-6 ndc (package): 70771-1746-3 ndc (package): 70771-1745-5 ndc (package): 70771-1746-9 ndc (package): 70771-1746-5 ndc (product): 70771-1746 ndc (product): 70771-1745 ndc11 (package): 70771174505 ndc11 (package): 70771174603 ndc11 (package): 70771174605 ndc11 (package): 70771174508 ndc11 (package): 70771174506 ndc11 (package): 70771174609 spl id: 1b288e91-dedb-465d-8c45-eb464dc72e89 spl set id: 6a029063-b14c-4eee-9958-0d9eecb27726

Reported adverse events (FAERS/openFDA)#

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