hydrocodone bitartrate and acetaminophen

Product NDC: 27808-130
11-digit product format: 278080130
Labeler code: 27808
Product ID: 27808-130_5b4bd464-17c3-42af-a519-ef795299e692
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocodone bitartrate and acetaminophen
Dosage form: SOLUTION
Route: ORAL
Labeler: Cranbury Pharmaceuticals, LLC
Application: ANDA201295
Marketing category: ANDA
Marketing start: 2021-12-30
Substance: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength: 300; 10 mg/15mL; mg/15mL
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule: CII
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL			2021-12-30
A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	300MG/15ML;10MG/15ML	SOLUTION / ORAL			2021-12-30

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 · 64 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	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2021-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL	AA	2021-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2021-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL	AA	2021-12-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL	AA	2021-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL	AA	2021-12-30	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201295-001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	325MG/15ML;7.5MG/15ML	SOLUTION / ORAL		2021-12-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201295-002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	300MG/15ML;10MG/15ML	SOLUTION / ORAL		2021-12-30	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A201295-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201295-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201295-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201295-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A201295-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201295-002	AA	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: hydrocodone bitartrate and acetaminophen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCODONE BITARTRATE	300 mg/15mL
ACETAMINOPHEN	10 mg/15mL

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
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1044427	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
93b6dfdf-ba6e-4ea6-ab85-5ac121e33101	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	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
27808-130-01	hydrocodone bitartrate and acetaminophen	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27808-130	HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [TRIS PHARMA INC]	17	Current NDC, Legacy NDC, 1 package rows	20240305_93b6dfdf-ba6e-4ea6-ab85-5ac121e33101.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 · 2 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	Cranbury Pharmaceuticals, LLC	93b6dfdf-ba6e-4ea6-ab85-5ac121e33101	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201295 application number: ANDA201295 ndc (product): 27808-130
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Cranbury Pharmaceuticals, LLC	57e1fe79-eb60-4f4f-bb38-6df0270d408f	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201295 application number: ANDA201295

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1044427	HYDROcodone bitartrate 10 MG / acetaminophen 300 MG in 15 mL Oral Solution	PSN	93b6dfdf-ba6e-4ea6-ab85-5ac121e33101	23
1044427	acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral Solution	SCD	93b6dfdf-ba6e-4ea6-ab85-5ac121e33101	23
1044427	APAP 20 MG/ML / Hydrocodone Bitartrate 0.667 MG/ML Oral Solution	SY	93b6dfdf-ba6e-4ea6-ab85-5ac121e33101	23
1044427	APAP 300 MG / hydrocodone bitartrate 10 MG per 15 ML Oral Solution	SY	93b6dfdf-ba6e-4ea6-ab85-5ac121e33101	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
27808-130-01	27808013001	473 mL in 1 BOTTLE, PLASTIC (27808-130-01)	473 ml	2022-12-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Acetaminophen Oral Solution (CII) 10 mg/300 mg per 15 mL Rx Only	Cranbury Pharmaceuticals, LLC	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	23