HYDROCODONE BITARTRATE

Product NDC: 61919-296
11-digit product format: 619190296
Labeler code: 61919
Product ID: 61919-296_3fdeac85-5fd8-04fa-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROCODONE BITARTRATE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA077723
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; IBUPROFEN
Active strength: 8 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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	61919-296		U	Excluded because listing certification expired		2026-08-03
excluded package	package	61919-296	61919-296-30	U	Excluded because listing certification expired		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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET / ORAL	2006-11-06
A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	10MG;200MG	TABLET / ORAL	2006-11-06
A077723-003	HYDROCODONE	HYDROCODONE BITARTRATE; IBUPROFEN	5MG;200MG	TABLET / ORAL	2006-11-06

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 3 · 114 observed 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	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL		2006-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL		2006-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL		2006-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL		2006-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL		2006-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL		2006-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL		2006-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL		2006-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL		2006-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL		2006-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL		2006-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL		2006-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2006-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2006-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2006-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2006-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2006-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2006-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2006-11-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077723-002	HYDROCODONE BITARTRATE AND IBUPROFEN	10MG;200MG	TABLET / ORAL		2006-11-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077723-003	HYDROCODONE	5MG;200MG	TABLET / ORAL	AB	2006-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077723-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2006-11-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077723-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077723-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077723-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077723-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077723-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077723-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077723-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077723-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077723-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077723-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077723-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077723-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077723-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077723-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077723-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077723-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077723-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077723-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077723-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077723-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077723-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077723-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077723-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077723-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077723-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077723-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077723-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077723-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077723-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077723-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077723-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077723-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077723-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077723-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077723-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077723-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077723-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077723-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077723-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077723-002	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
31b11e56-5b35-4ab6-a3a8-f0b48973dced	Product name	2	20200611
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
7855f8e3-562e-4273-8b79-0059c07a71f7	Product name	1	20170901
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
a5244f9c-cd67-0e27-d63b-65fd7e584400	Product name	2	20170504
b654f2d9-ebeb-451d-96ee-22f583344623	Product name	1	20170424
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-296-30	HYDROCODONE BITARTRATE	30 in 1 BOTTLE	TABLET, COATED	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-296-30	EA - Each	61919-296	d0341581-bf81-4ce5-8cad-296ed9f2ebc3	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	1
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-296	HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX]	2	Legacy NDC, 1 package rows	20161028_c386c4c5-f2f1-4078-a6fb-f120f56912e4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
858798	HYDROcodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet	PSN	c386c4c5-f2f1-4078-a6fb-f120f56912e4	2
858798	hydrocodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet	SCD	c386c4c5-f2f1-4078-a6fb-f120f56912e4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-296-30	61919029630	30 in 1 BOTTLE	Historical