Promethazine with Codeine

Product NDC: 60432-606
11-digit product format: 604320606
Labeler code: 60432
Product ID: 60432-606_525b44c5-5457-437e-b7fd-19a9782bc35e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: promethazine hydrochloride and codeine phosphate
Dosage form: SOLUTION
Route: ORAL
Labeler: Morton Grove Pharmaceuticals, Inc.
Application: ANDA088875
Marketing category: ANDA
Marketing start: 1984-12-17
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: 2021-12-31
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	60432-606		I	Inactivated by FDA		2026-09-09
excluded package	package	60432-606	60432-606-16	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 · 30 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	60432-606-16	`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	60432-606-16	`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	60432-606-16	`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	60432-606-16	`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	60432-606-16	`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	60432-606-16	`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	60432-606-16	`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	60432-606-16	`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	60432-606-16	`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	60432-606-16	`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	60432-606-16	`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	60432-606-16	`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	60432-606-16	`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	60432-606-16	`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	60432-606-16	`1332a3947898…`	`d4bfe170f9cd…`

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
A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		1984-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088875-001	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 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	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088875-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	1984-12-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A088875-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088875-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088875-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088875-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088875-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088875-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088875-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088875-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088875-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088875-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088875-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088875-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088875-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088875-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088875-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088875-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088875-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088875-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088875-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088875-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088875-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088875-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088875-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088875-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088875-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088875-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088875-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088875-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088875-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088875-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088875-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088875-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088875-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088875-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088875-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088875-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088875-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088875-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088875-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088875-001	AA	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3036445d-7d13-4411-a100-f2ac5ab8a276	Product name	1	20240110
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
4f881de7-085a-407e-abc2-faa3c0127432	Product name	1	20170811
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60432-606-16	2023-01-30	C162847	48780-1	f386c64a-327c-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use PROMETHAZINE WITH CODEINE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE WITH CODEINE ORAL SOLUTION Initial U.S. Approval:1952

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60432-606-16	Promethazine with Codeine	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60432-606-16	ML - Milliliter	60432-606	5d051b83-0a38-469d-b706-a5fa632b7846	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Codeine Phosphate	ACTIVE INGREDIENT	GSL05Y1MN6	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
Promethazine Hydrochloride	ACTIVE INGREDIENT	R61ZEH7I1I	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
Codeine Anhydrous	ACTIVE MOIETY	UX6OWY2V7J	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
Promethazine	ACTIVE MOIETY	FF28EJQ494	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
SODIUM PROPIONATE ANHYDROUS	INACTIVE INGREDIENT	391O0PO49R	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROMETHAZINE WITH CODEINE COUGH (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60432-606	PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]	12	Legacy NDC, 1 package rows	20200507_eb9ac8c2-ee04-4eed-9b0e-a25d46a7a044.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	eb9ac8c2-ee04-4eed-9b0e-a25d46a7a044	12
991486	codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	eb9ac8c2-ee04-4eed-9b0e-a25d46a7a044	12
991486	codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup	SY	eb9ac8c2-ee04-4eed-9b0e-a25d46a7a044	12
991486	codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution	PSN	bba2e022-299e-5927-e053-2995a90a35f1	3
991486	codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	bba2e022-299e-5927-e053-2995a90a35f1	3
991486	codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup	SY	bba2e022-299e-5927-e053-2995a90a35f1	3
991486	codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution	PSN	ab0d0c01-34e8-4b78-b375-61e921f763de	2
991486	codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution	PSN	e1d6f54f-4e87-469f-9a44-11ca3a28cbfc	2
991486	codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	ab0d0c01-34e8-4b78-b375-61e921f763de	2
991486	codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	e1d6f54f-4e87-469f-9a44-11ca3a28cbfc	2
991486	codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup	SY	ab0d0c01-34e8-4b78-b375-61e921f763de	2
991486	codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup	SY	e1d6f54f-4e87-469f-9a44-11ca3a28cbfc	2
991486	codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution	PSN	0a0ce6c1-c683-4bfe-8245-6b755eeb2eac	1
991486	codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution	SCD	0a0ce6c1-c683-4bfe-8245-6b755eeb2eac	1
991486	codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup	SY	0a0ce6c1-c683-4bfe-8245-6b755eeb2eac	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60432-606-16	60432060616	473 mL in 1 BOTTLE, PLASTIC (60432-606-16)	473 ml	1984-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Promethazine with Codeine	ATLANTIC BIOLOGICALS CORP.	2021-01-25	HUMAN PRESCRIPTION DRUG LABEL	2
PROMETHAZINE WITH CODEINE ORAL SOLUTION	RedPharm Drug, Inc. \| Unit Dose Solutions, Inc.	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Promethazine with Codeine	Morton Grove Pharmaceuticals, Inc.	2020-05-05	HUMAN PRESCRIPTION DRUG LABEL	12
Promethazine with Codeine	A-S Medication Solutions	2019-02-14	HUMAN PRESCRIPTION DRUG LABEL	2
Promethazine with Codeine	Lohxa	2018-02-22	HUMAN PRESCRIPTION DRUG LABEL	1