POSACONAZOLE

Product NDC: 70748-258
11-digit product format: 707480258
Labeler code: 70748
Product ID: 70748-258_ef76e94c-f183-4eef-8fee-a52635cdcd34
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: POSACONAZOLE
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA213454
Marketing category: ANDA
Marketing start: 2021-02-17
Substance: POSACONAZOLE
Active strength: 100 mg/1
Pharmacologic classes: Azole Antifungal [EPC], Azoles [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 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
A213454-001	POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2021-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213454-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2021-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2021-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2021-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2021-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2021-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2021-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2021-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2021-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2021-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2021-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-02-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213454-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2021-02-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213454-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213454-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213454-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213454-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213454-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213454-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213454-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213454-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213454-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213454-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213454-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213454-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213454-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213454-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213454-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213454-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213454-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213454-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213454-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213454-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213454-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213454-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213454-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213454-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213454-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213454-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213454-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213454-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213454-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213454-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213454-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213454-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213454-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213454-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213454-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: POSACONAZOLE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POSACONAZOLE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6TK1G07BHZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1482908	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
548124ce-8050-46a9-967b-ff23dfb18633	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc1eab98-5691-4d9a-82e4-7e2823a44fa6	Product name	9	20251124
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70748-258-07	POSACONAZOLE	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70748-258-07	EA - Each	70748-258	7e914c22-ca19-452e-81c4-8390e83db20a	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70748-258	POSACONAZOLE TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20250221_548124ce-8050-46a9-967b-ff23dfb18633.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POSACONAZOLE	POSACONAZOLE	Major Pharmaceuticals	8e1e69b8-cf41-47cc-a3ec-1baee55f099a	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213454 application number: ANDA213454
POSACONAZOLE	POSACONAZOLE	Lupin Pharmaceuticals, Inc.	548124ce-8050-46a9-967b-ff23dfb18633	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213454 application number: ANDA213454 ndc (product): 70748-258

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6TK1G07BHZ	POSACONAZOLE	171228-49-2	POSACONAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1482908	posaconazole 100 MG Delayed Release Oral Tablet	PSN	548124ce-8050-46a9-967b-ff23dfb18633	9
1482908	posaconazole 100 MG Delayed Release Oral Tablet	SCD	548124ce-8050-46a9-967b-ff23dfb18633	9
1482908	posaconazole 100 MG Delayed Release Oral Tablet	PSN	8e1e69b8-cf41-47cc-a3ec-1baee55f099a	7
1482908	posaconazole 100 MG Delayed Release Oral Tablet	SCD	8e1e69b8-cf41-47cc-a3ec-1baee55f099a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70748-258-07	70748025807	60 TABLET, DELAYED RELEASE in 1 BOTTLE (70748-258-07)	2021-02-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POSACONAZOLE	Major Pharmaceuticals	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	8
POSACONAZOLE	Lupin Pharmaceuticals, Inc. \| AET LABORATORIES PRIVATE LIMITED \| MSN Laboratories Private Limited 317, 320, 321, 322, 323, 604 & 605, Rudraram, Patancheru (Mandal), Sangareddy District, Telangana 502329, India	2026-05-07	HUMAN PRESCRIPTION DRUG LABEL	9