Promethazine with Codeine

Product NDC: 50436-1029
11-digit product format: 504361029
Labeler code: 50436
Product ID: 50436-1029_a5ea91e6-6323-46bf-abf2-260d887ce56c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride and Codeine Phosphate
Dosage form: SOLUTION
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA040650
Marketing category: ANDA
Marketing start: 2006-01-31
Marketing end: 0000-00-00
Substance: PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
Active strength: 6 mg/5mL; mg/5mL
Pharmacologic classes: Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50436-1029		I	Inactivated by FDA		2026-09-09
excluded package	package	50436-1029	50436-1029-1	I	Inactivated by FDA		2026-09-09

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-1029-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-1029-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-1029-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-1029-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-1029-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-1029-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-1029-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-1029-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-1029-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-1029-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-1029-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-1029-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-1029-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-1029-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-1029-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50436-1029-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50436-1029-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50436-1029-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50436-1029-1	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040650-001	PROMETHAZINE WITH CODEINE	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL			2006-01-31

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 · 42 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
2026-08-18 06:07:40	2026-07	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		2006-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		2006-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		2006-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		2006-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		2006-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		2006-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL		2006-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040650-001	PROMETHAZINE WITH CODEINE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	2006-01-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040650-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040650-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040650-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040650-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040650-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040650-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040650-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040650-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040650-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040650-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040650-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040650-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040650-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040650-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040650-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040650-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040650-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040650-001	AA	1	`8869cabd3fbd…`
2019-12-14 00:12 UTC	2019-12	A040650-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040650-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040650-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040650-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040650-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040650-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040650-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040650-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040650-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040650-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040650-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040650-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040650-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040650-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040650-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040650-001	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
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
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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-1029-1	2021-01-29	C162847	48780-1	ba0f9c33-4119-a910-e053-dadaa90a0b85	Promethazine with Codeine Oral Solution (Promethazine HCl and Codeine Phosphate Oral Solution)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-1029-1	Promethazine with Codeine	120 mL in 1 BOTTLE	SOLUTION	120		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-1029	PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SOLUTION [UNIT DOSE SERVICES]	8	Legacy NDC, 1 package rows	20171108_e41b8b94-be20-4706-9454-e98c46731ab1.zip

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

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	e41b8b94-be20-4706-9454-e98c46731ab1	8
991486	codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	e41b8b94-be20-4706-9454-e98c46731ab1	8
991486	codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup	SY	e41b8b94-be20-4706-9454-e98c46731ab1	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50436-1029-1	50436102901	120 mL in 1 BOTTLE	120 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine with Codeine Oral Solution (Promethazine HCl and Codeine Phosphate Oral Solution)	Unit Dose Services	2017-11-07	HUMAN PRESCRIPTION DRUG LABEL	8