Hydrocodone Bitartrate and Ibuprofen

Product NDC: 13107-004
11-digit product format: 131070004
Labeler code: 13107
Product ID: 13107-004_ef408ee9-6806-423f-9998-53d81cc71b94
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurolife Pharma, LLC
Application: ANDA204575
Marketing category: ANDA
Marketing start: 2016-06-02
Substance: HYDROCODONE BITARTRATE; IBUPROFEN
Active strength: 7.5; 200 mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule: CII
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
A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB		2016-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204575-001	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.

Product history page 1 of 2 · 41 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	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204575-001	HYDROCODONE BITARTRATE AND IBUPROFEN	7.5MG;200MG	TABLET / ORAL	AB	2016-06-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204575-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204575-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204575-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204575-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204575-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204575-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204575-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204575-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204575-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204575-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204575-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204575-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204575-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204575-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204575-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204575-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204575-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204575-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204575-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204575-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204575-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204575-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204575-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204575-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204575-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204575-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204575-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204575-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204575-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204575-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204575-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204575-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204575-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204575-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204575-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204575-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204575-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204575-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204575-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204575-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydrocodone Bitartrate and Ibuprofen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCODONE BITARTRATE	7.5 mg/1
IBUPROFEN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NO70W886KK	Internal UNII lookup
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858798	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
470df63a-5c0f-42df-9023-a330a901153e	Available on FDA.report

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	SPL version
13107-004-01	Hydrocodone Bitartrate and Ibuprofen	100 in 1 BOTTLE	TABLET, FILM COATED	100	21
13107-004-05	Hydrocodone Bitartrate and Ibuprofen	500 in 1 BOTTLE	TABLET, FILM COATED	500	21
13107-004-11	Hydrocodone Bitartrate and Ibuprofen	10 in 1 BOTTLE	TABLET, FILM COATED	10	21
13107-004-99	Hydrocodone Bitartrate and Ibuprofen	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13107-004-01	EA - Each	13107-004	e697ba03-572d-4de0-aabc-f81582cc6609	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-004	HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AUROLIFE PHARMA, LLC]	19	Current NDC, Legacy NDC, 4 package rows	20240802_470df63a-5c0f-42df-9023-a330a901153e.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
Hydrocodone Bitartrate and Ibuprofen	HYDROCODONE BITARTRATE AND IBUPROFEN	Aurolife Pharma, LLC	470df63a-5c0f-42df-9023-a330a901153e	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204575 application number: ANDA204575 ndc (product): 13107-004

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	470df63a-5c0f-42df-9023-a330a901153e	21
858798	hydrocodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet	SCD	470df63a-5c0f-42df-9023-a330a901153e	21
858798	HYDROcodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet	PSN	8909cfeb-e928-82b5-e053-2995a90a71b8	3
858798	hydrocodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet	SCD	8909cfeb-e928-82b5-e053-2995a90a71b8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13107-004-01	13107000401	100 TABLET, FILM COATED in 1 BOTTLE (13107-004-01)	2016-06-02	0000-00-00	No	No	Current
13107-004-05	13107000405	500 TABLET, FILM COATED in 1 BOTTLE (13107-004-05)	2016-06-02	0000-00-00	No	No	Current
13107-004-11	13107000411	10 TABLET, FILM COATED in 1 BOTTLE (13107-004-11)	2016-06-02	0000-00-00	No	No	Current
13107-004-99	13107000499	1000 TABLET, FILM COATED in 1 BOTTLE (13107-004-99)	2016-06-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS C-II 7.5 mg/200 mg	Aurolife Pharma, LLC	2025-12-23	Human Prescription Drug Label	21
HYDROCODONE/IBU 7.5/200mg	RedPharm Drug, Inc.	2024-08-09	HUMAN PRESCRIPTION DRUG LABEL	3