Hydrocodone Bitartrate and Homatropine Methylbromide

Product NDC: 0121-1036
11-digit product format: 001211036
Labeler code: 0121
Product ID: 0121-1036_17bce1b5-fe40-42c4-b167-51f48ea47c9e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage form: SOLUTION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: NDA005213
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-08-05
Substance: HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
Active strength: 5; 1.5 mg/5mL; mg/5mL
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 43.

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
N005213-001	HYCODAN	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26
N005213-002	HYCODAN	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N005213-001	AA
N005213-002	AA

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N005213-001	HYCODAN	1.5MG;5MG	TABLET / ORAL	AA	RLD	1988-07-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RLD	1988-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N005213-001	HYCODAN	1.5MG;5MG	TABLET / ORAL	AA	RLD	1988-07-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RLD	1988-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1988-07-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N005213-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N005213-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N005213-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N005213-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N005213-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N005213-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005213-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005213-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N005213-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N005213-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005213-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005213-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005213-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005213-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005213-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005213-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005213-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005213-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005213-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005213-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005213-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005213-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N005213-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N005213-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N005213-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N005213-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005213-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005213-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N005213-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N005213-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N005213-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N005213-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N005213-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N005213-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N005213-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N005213-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N005213-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N005213-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N005213-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N005213-001	AA	1	`bb7c543d1eb4…`

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: Hydrocodone Bitartrate and Homatropine Methylbromide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCODONE BITARTRATE	5 mg/5mL
HOMATROPINE METHYLBROMIDE	1.5 mg/5mL

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
68JRS2HC1C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992668	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
71319a6f-aaf4-4bc5-8b40-a16c6f139be6	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
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	SPL version
0121-1036-05	Hydrocodone Bitartrate and Homatropine Methylbromide	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	1
0121-1036-40	Hydrocodone Bitartrate and Homatropine Methylbromide	4 in 1 CASE	SOLUTION	4	1
0121-1036-40	Hydrocodone Bitartrate and Homatropine Methylbromide	10 in 1 TRAY	SOLUTION	10	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-1036-05	ML - Milliliter	0121-1036	78549541-6f93-40b9-b2e5-0d09023c2e18	1	2024-08-12
0121-1036-40	ML - Milliliter	0121-1036	70ad9a4b-8118-4efc-a2a1-83f5ed2c5687	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-1036	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	1	Current NDC, 3 package rows	20240806_71319a6f-aaf4-4bc5-8b40-a16c6f139be6.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 Homatropine Methylbromide	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	Genus Lifesciences Inc.	320ff639-9854-407b-9bbd-a035c4f173e1	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 005213 application number: NDA005213
Hydrocodone Bitartrate and Homatropine Methylbromide	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	PAI Holdings, LLC dba PAI Pharma	71319a6f-aaf4-4bc5-8b40-a16c6f139be6	2026-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 005213 application number: NDA005213 ndc (product): 0121-1036

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE
68JRS2HC1C	HOMATROPINE METHYLBROMIDE	80-49-9	HOMATROPINE METHYLBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
992668	HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution	PSN	71319a6f-aaf4-4bc5-8b40-a16c6f139be6	1
992668	homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution	SCD	71319a6f-aaf4-4bc5-8b40-a16c6f139be6	1
992668	homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup	SY	71319a6f-aaf4-4bc5-8b40-a16c6f139be6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0121-1036-05	00121103605	5 mL in 1 CUP, UNIT-DOSE	5 ml				Historical
0121-1036-40	00121103640	4 TRAY in 1 CASE (0121-1036-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05)	4 tray	2024-08-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Homatropine Methylbromide	PAI Holdings, LLC dba PAI Pharma	2026-02-28	HUMAN PRESCRIPTION DRUG LABEL	2