Aptivus

Product NDC: 0597-0003
11-digit product format: 005970003
Labeler code: 0597
Product ID: 0597-0003_089edede-222a-4895-ac85-82b775ef3352
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tipranavir
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: NDA021814
Marketing category: NDA
Marketing start: 2005-07-01
Substance: TIPRANAVIR
Active strength: 250 mg/1
Pharmacologic classes: HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0597-0003		I	Inactivated by FDA		2026-08-03
excluded package	package	0597-0003	0597-0003-02	I	Inactivated by FDA		2026-08-03

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
N021814-001	APTIVUS	TIPRANAVIR	250MG	CAPSULE / ORAL		RLD, RS	2005-06-22

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021814-001	APTIVUS	250MG	CAPSULE / ORAL	RLD, RS	2005-06-22	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021814-001	6231887*PED	2019-01-27		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021814-001	5852195	2019-06-22		Drug substance	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021814-001	6147095	2019-10-29	U-670		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021814-001	5852195*PED	2019-12-22		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021814-001	6147095*PED	2020-04-29		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021814-001	6147095*PED	2020-04-29		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021814-001	6147095*PED	2020-04-29		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021814-001	6231887*PED	2019-01-27		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021814-001	5852195	2019-06-22		Drug substance	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021814-001	6147095	2019-10-29	U-670		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021814-001	5852195*PED	2019-12-22		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021814-001	6147095*PED	2020-04-29		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021814-001	6231887*PED	2019-01-27		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021814-001	5852195	2019-06-22		Drug substance	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021814-001	6147095	2019-10-29	U-670		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021814-001	5852195*PED	2019-12-22		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021814-001	6147095*PED	2020-04-29		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021814-001	6231887*PED	2019-01-27		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021814-001	5852195	2019-06-22		Drug substance	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021814-001	6147095	2019-10-29	U-670		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021814-001	5852195*PED	2019-12-22		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021814-001	6147095*PED	2020-04-29		Pediatric extension	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d546ba7f-d76b-ca37-803f-01860333d2f5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0597-0003-02	Aptivus	120 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	120		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0003-02	EA - Each	0597-0003	20dae680-091a-4f62-b9bc-f15e3a6f0c5f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
tipranavir	ACTIVE INGREDIENT	ZZT404XD09	APTIVUS (TIPRANAVIR) CAPSULE, LIQUID FILLED APTIVUS (TIPRANAVIR) SOLUTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	9
tipranavir	ACTIVE MOIETY	ZZT404XD09	APTIVUS (TIPRANAVIR) CAPSULE, LIQUID FILLED APTIVUS (TIPRANAVIR) SOLUTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0597-0003	APTIVUS (TIPRANAVIR) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	18	Current NDC, Legacy NDC, 1 package rows	20240524_08982e49-d2eb-4b25-b01a-1be52fd669ef.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZZT404XD09	TIPRANAVIR	174484-41-4	TIPRANAVIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
603378	Aptivus 250 MG Oral Capsule	PSN	08982e49-d2eb-4b25-b01a-1be52fd669ef	19
577212	tipranavir 250 MG Oral Capsule	PSN	08982e49-d2eb-4b25-b01a-1be52fd669ef	19
603378	tipranavir 250 MG Oral Capsule [Aptivus]	SBD	08982e49-d2eb-4b25-b01a-1be52fd669ef	19
577212	tipranavir 250 MG Oral Capsule	SCD	08982e49-d2eb-4b25-b01a-1be52fd669ef	19
603378	Aptivus 250 MG Oral Capsule	SY	08982e49-d2eb-4b25-b01a-1be52fd669ef	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0597-0003-02	00597000302	120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0597-0003-02)	2005-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aptivus	Boehringer Ingelheim Pharmaceuticals, Inc. \| West-Ward Columbus Inc. \| Catalent Pharma Solutions \| Boehringer Ingelheim Pharma GmbH and Co. KG \| Porton Pharma Solutions Ltd.	2025-06-18	HUMAN PRESCRIPTION DRUG LABEL	19