Promethazine Hydrochloride and Codeine Phosphate

Product NDC: 12634-909
11-digit product format: 126340909
Labeler code: 12634
Product ID: 12634-909_49d71d3b-fb89-5738-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Promethazine Hydrochloride and Codeine Phosphate
Dosage form: SYRUP
Route: ORAL
Labeler: Apotheca Inc
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: 2019-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-909		I	Inactivated by FDA	2026-09-14
excluded package	package	12634-909	12634-909-02	I	Inactivated by FDA	2026-09-14
excluded package	package	12634-909	12634-909-04	I	Inactivated by FDA	2026-09-14
excluded package	package	12634-909	12634-909-06	I	Inactivated by FDA	2026-09-14
excluded package	package	12634-909	12634-909-08	I	Inactivated by FDA	2026-09-14
excluded package	package	12634-909	12634-909-16	I	Inactivated by FDA	2026-09-14
excluded package	package	12634-909	12634-909-28	I	Inactivated by FDA	2026-09-14
excluded package	package	12634-909	12634-909-32	I	Inactivated by FDA	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 3 · 168 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	12634-909-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-909-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-909-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-909-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-909-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-909-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-909-04	`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	12634-909-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-909-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-909-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-909-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-909-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-909-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-909-04	`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	12634-909-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-909-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-909-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-909-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-909-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-909-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-909-04	`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	12634-909-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-909-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-909-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-909-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-909-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-909-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-909-04	`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	12634-909-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-909-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-909-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-909-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-909-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-909-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-909-04	`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	12634-909-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	12634-909-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	12634-909-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	12634-909-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	12634-909-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	12634-909-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	12634-909-04	`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	12634-909-32	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	12634-909-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	12634-909-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	12634-909-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	12634-909-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	12634-909-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	12634-909-04	`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	12634-909-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	12634-909-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	12634-909-28	`ed331223b511…`	`672a5bd82f5f…`

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
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, Related label table
NDC	Related label
12634-909-02	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP
12634-909-04	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP
12634-909-06	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP
12634-909-08	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP
12634-909-16	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP
12634-909-28	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP
12634-909-32	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-909-02	Promethazine Hydrochloride and Codeine Phosphate	60 mL in 1 BOTTLE	SYRUP	60	5
12634-909-04	Promethazine Hydrochloride and Codeine Phosphate	120 mL in 1 BOTTLE	SYRUP	120	5
12634-909-06	Promethazine Hydrochloride and Codeine Phosphate	178 mL in 1 BOTTLE	SYRUP	178	5
12634-909-08	Promethazine Hydrochloride and Codeine Phosphate	237 mL in 1 BOTTLE	SYRUP	237	5
12634-909-16	Promethazine Hydrochloride and Codeine Phosphate	473 mL in 1 BOTTLE	SYRUP	473	5
12634-909-28	Promethazine Hydrochloride and Codeine Phosphate	3785 mL in 1 BOTTLE	SYRUP	3785	5
12634-909-32	Promethazine Hydrochloride and Codeine Phosphate	946 mL in 1 BOTTLE	SYRUP	946	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
12634-909	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA INC]	5	Legacy NDC, 7 package rows	20170327_47d4eb4f-6dd4-44b9-aea1-19c4bfc1d425.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	Status
12634-909-02	12634090902	60 mL in 1 BOTTLE	60 ml	Historical
12634-909-04	12634090904	120 mL in 1 BOTTLE	120 ml	Historical
12634-909-06	12634090906	178 mL in 1 BOTTLE	178 ml	Historical
12634-909-08	12634090908	237 mL in 1 BOTTLE	237 ml	Historical
12634-909-16	12634090916	473 mL in 1 BOTTLE	473 ml	Historical
12634-909-28	12634090928	3785 mL in 1 BOTTLE	3785 ml	Historical
12634-909-32	12634090932	946 mL in 1 BOTTLE	946 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP	Apotheca Inc \| Apotheca Inc.	2017-03-03	HUMAN PRESCRIPTION DRUG LABEL	5