Promethazine Hydrochloride and Codeine Phosphate

Product NDC
17856-0139
Requested package NDC
17856-0139-1
11-digit product format
178560139
Labeler code
17856
Product ID
17856-0139_2e141e93-7423-42f3-87cb-203dcc2192f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride and Codeine Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA214238
Marketing category
ANDA
Marketing start
2020-10-08
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
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage17856-013917856-0139-1IInactivated by FDA2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214238-001AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-084b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-088869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214238-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORALAA2020-10-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214238-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214238-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214238-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214238-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214238-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214238-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214238-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214238-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214238-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214238-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214238-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214238-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214238-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214238-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214238-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214238-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214238-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214238-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214238-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214238-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214238-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A214238-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A214238-001AA18869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214238-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214238-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214238-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214238-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214238-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214238-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214238-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A214238-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A214238-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214238-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214238-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214238-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214238-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214238-001AA1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0139-1Promethazine Hydrochloride and Codeine Phosphate72 in 1 BOX, UNIT-DOSESOLUTION721
17856-0139-1Promethazine Hydrochloride and Codeine Phosphate5 mL in 1 CUP, UNIT-DOSESOLUTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0139PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 2 package rows20210624_da31f63b-08d3-421c-8bc9-fd18029bf0a9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEQUAGEN PHARMACEUTICALS LLC9aca56ec-28f8-4679-9f90-ec3e82deb9ac2023-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214238
application number: ANDA214238

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNda31f63b-08d3-421c-8bc9-fd18029bf0a91
991486codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDda31f63b-08d3-421c-8bc9-fd18029bf0a91
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral SyrupSYda31f63b-08d3-421c-8bc9-fd18029bf0a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0139-11785601390172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0139-1) > 5 mL in 1 CUP, UNIT-DOSE2021-06-230000-00-00NoNoCurrent