POSACONAZOLE

Product NDC: 70377-038
11-digit product format: 703770038
Labeler code: 70377
Product ID: 70377-038_b7a2fd29-83b5-6ae6-775c-98f91a6c0ea4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Posaconazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Biocon Phama Inc.
Application: ANDA214476
Marketing category: ANDA
Marketing start: 2022-03-08
Substance: POSACONAZOLE
Active strength: 100 mg/1
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A214476-001	POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2022-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214476-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`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	A214476-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214476-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214476-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214476-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214476-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214476-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214476-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214476-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214476-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214476-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214476-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214476-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214476-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214476-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214476-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214476-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214476-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214476-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214476-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214476-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214476-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214476-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214476-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214476-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214476-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214476-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214476-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214476-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214476-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214476-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214476-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214476-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: POSACONAZOLE
Listing expiration: 2026-12-31

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
e0e8023a-3c82-e455-a57b-ccc0206ad156	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
70377-038-11	POSACONAZOLE	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70377-038-11	EA - Each	70377-038	714ae3d5-4d8b-435c-9dbc-1359d2895a52	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70377-038	POSACONAZOLE TABLET, DELAYED RELEASE [BIOCON PHAMA INC.]	12	Current NDC, Legacy NDC, 1 package rows	20220429_e0e8023a-3c82-e455-a57b-ccc0206ad156.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POSACONAZOLE	POSACONAZOLE	Biocon Phama Inc.	e0e8023a-3c82-e455-a57b-ccc0206ad156	2022-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214476 application number: ANDA214476 ndc (product): 70377-038

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	e0e8023a-3c82-e455-a57b-ccc0206ad156	12
1482908	posaconazole 100 MG Delayed Release Oral Tablet	SCD	e0e8023a-3c82-e455-a57b-ccc0206ad156	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70377-038-11	70377003811	60 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-038-11)	2022-03-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POSACONAZOLE	Biocon Phama Inc. \| Biocon Pharma Limited \| Biocon Limited	2022-04-27	HUMAN PRESCRIPTION DRUG LABEL	12