POSACONAZOLE

Product NDC: 70377-038
11-digit product format: 703770038
Labeler code: 70377
Product ID: 70377-038_6cc9af25-9b9b-f5d8-33f2-09975d6998ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Posaconazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Biocon Pharma 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: 2027-12-31
Current FDA listing: Yes

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

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
2026-10-15 13:18:30	2026-09	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214476-001	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-02-04	`caaa826d4ba7…`
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
2026-10-15 13:18:30	2026-09	A214476-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214476-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214476-001	AB	1	`caaa826d4ba7…`
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…`

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: POSACONAZOLE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POSACONAZOLE	100 mg/1

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

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 Pharma Inc. \| Biocon Pharma Limited \| Biocon Limited	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	16