Promethazine Hydrochloride and Codeine Phosphate

Product NDC: 50383-804
11-digit product format: 503830804
Labeler code: 50383
Product ID: 50383-804_6994efab-2353-4868-bcde-c3ee3a2b1e8e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride and Codeine Phosphate
Dosage form: SOLUTION
Route: ORAL
Labeler: Akorn
Application: ANDA040151
Marketing category: ANDA
Marketing start: 1997-08-26
Marketing end: 0000-00-00
Substance: CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Active strength: 10 mg/5mL; mg/5mL
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50383-804		D	Discontinued by firm	2026-09-14
excluded package	package	50383-804	50383-804-04	D	Discontinued by firm	2026-09-14
excluded package	package	50383-804	50383-804-16	D	Discontinued by firm	2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 34 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-804-16	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-804-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-804-16	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-804-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-804-16	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-804-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-804-16	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-804-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-804-16	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-804-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-804-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-804-04	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-804-16	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-804-04	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-804-16	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-804-04	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-804-16	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-804-04	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-804-16	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-804-04	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-804-16	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-804-04	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50383-804-04	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL			1997-08-26

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 · 43 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
2026-09-14 22:38:34	2026-08	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		1997-08-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040151-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1997-08-26	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

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	A040151-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040151-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040151-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040151-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040151-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040151-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040151-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040151-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040151-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040151-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040151-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040151-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040151-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040151-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040151-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040151-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040151-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040151-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040151-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040151-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040151-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040151-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040151-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040151-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040151-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040151-001	AA	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3036445d-7d13-4411-a100-f2ac5ab8a276	Product name	1	20240110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2e7222fb-e3f1-febd-962f-ddbb495d6b5f	Product name	2	20220126
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
4f881de7-085a-407e-abc2-faa3c0127432	Product name	1	20170811
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
e9576821-a971-5261-628e-82ad9e10acdb	Product name	2	20150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
ce055423-1d7f-3c41-dff1-83660fa8cd96	Product name	1	20140508
d51697af-7f97-0559-95d1-fe94f3f031d5	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50383-804-04	2025-12-17	These highlights do not include all the information needed to use [PROMETHAZINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCl AND CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952
50383-804-16	2025-12-17	These highlights do not include all the information needed to use [PROMETHAZINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCl AND CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952
50383-804-04	2024-07-30	These highlights do not include all the information needed to use [PROMETHAZINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCl AND CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952
50383-804-16	2024-07-30	These highlights do not include all the information needed to use [PROMETHAZINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCl AND CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952
50383-804-04	2024-01-30	These highlights do not include all the information needed to use [PROMETHAZINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCl AND CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952
50383-804-16	2024-01-30	These highlights do not include all the information needed to use [PROMETHAZINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCl AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCl AND CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-804-16	ML - Milliliter	50383-804	0214014c-8080-4415-8bc1-e2523bd65949	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.]	12
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]	2
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
PROMETHAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
CODEINE	ACTIVE MOIETY	Q830PW7520	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
PROMETHAZINE	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
CITRIC ACID	INACTIVE INGREDIENT	2968PHW8QP	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-804	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION [AKORN]	28	Legacy NDC	20230112_168951c0-773d-4f3d-9745-cc6de2063b61.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GSL05Y1MN6	CODEINE PHOSPHATE	41444-62-6	CODEINE PHOSPHATE
R61ZEH7I1I	PROMETHAZINE HYDROCHLORIDE	58-33-3	PROMETHAZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
991486	codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution	PSN	47d4eb4f-6dd4-44b9-aea1-19c4bfc1d425	5
991486	codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	47d4eb4f-6dd4-44b9-aea1-19c4bfc1d425	5
991486	codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup	SY	47d4eb4f-6dd4-44b9-aea1-19c4bfc1d425	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-804-04	50383080404	118 mL in 1 BOTTLE (50383-804-04)	118 ml	1997-08-26	0000-00-00	No	No	Current
50383-804-16	50383080416	473 mL in 1 BOTTLE (50383-804-16)	473 ml	1997-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine Hydrochloride and Codeine Phosphate	Akorn \| Akorn Operating Company LLC	2023-01-11	HUMAN PRESCRIPTION DRUG LABEL	28
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP	Apotheca Inc \| Apotheca Inc.	2017-03-03	HUMAN PRESCRIPTION DRUG LABEL	5
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP	Atlantic Biologicals Corps	2012-04-13	HUMAN PRESCRIPTION DRUG LABEL	2