Application 206245

Type: ANDA
Sponsor: NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	325MG;5MG	No	No
002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	325MG;7.5MG	No	No
003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	325MG;10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;5MG	TABLET / ORAL	2016-12-01
A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;7.5MG	TABLET / ORAL	2016-12-01
A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG;10MG	TABLET / ORAL	2016-12-01

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206245-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2016-12-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206245-003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2016-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206245-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2016-12-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206245-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206245-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206245-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206245-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206245-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206245-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206245-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206245-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206245-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206245-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206245-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206245-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206245-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206245-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206245-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206245-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206245-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206245-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206245-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206245-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206245-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206245-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206245-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206245-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206245-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206245-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206245-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206245-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206245-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206245-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206245-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206245-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206245-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206245-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206245-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206245-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206245-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206245-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206245-003	AA	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206245-001	AA	1	`a72a2bbeb626…`

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
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Lupin Pharmaceuticals,Inc.	26a2178e-e0e5-4d61-81fd-e30a3142f1f2	2024-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206245 application number: ANDA206245 ndc (product): 43386-358 ndc (product): 43386-356 ndc (product): 43386-357

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6824	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-6824	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-6824	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-6825	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-6825	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-6825	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-6826	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-6826	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Major Pharmaceuticals	ANDA	Current
0904-6826	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Major Pharmaceuticals	ANDA	Current
40032-356	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Novel Laboratories, Inc.	ANDA	Current
40032-356	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Novel Laboratories, Inc.	ANDA	Current
40032-357	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Novel Laboratories, Inc.	ANDA	Current
40032-357	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Novel Laboratories, Inc.	ANDA	Current
40032-358	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Novel Laboratories, Inc.	ANDA	Current
40032-358	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Novel Laboratories, Inc.	ANDA	Current
43386-356	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-356	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-356	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-357	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-357	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-357	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-358	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-358	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-358	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Lupin Pharmaceuticals,Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76133	ORIG	2023-11-03