Home NDC 17856-0059 promethazine hydrochloride
Product NDC 17856-0059
11-digit product format 178560059
Labeler code 17856
Product ID 17856-0059_45b43457-b9cd-09a2-e063-6294a90a698d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name promethazine hydrochloride
Dosage form SYRUP
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP
Application ANDA091675
Marketing category ANDA
Marketing start 2012-06-08
Substance PROMETHAZINE HYDROCHLORIDE
Active strength 6.25 mg/5mL
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 14 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 2025-04-01 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 17856-0059-1 I Inactivated by FDA 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 17856-0059-1 I Inactivated by FDA 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 17856-0059-1 I Inactivated by FDA 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 17856-0059-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 17856-0059-1 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 17856-0059-1 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 17856-0059-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A091675-001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091675-001 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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091675-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2012-06-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base promethazine hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R61ZEH7I1I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992432 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0059-1 promethazine hydrochloride 72 in 1 BOX, UNIT-DOSE SYRUP 72 4 17856-0059-1 promethazine hydrochloride 5 mL in 1 CUP, UNIT-DOSE SYRUP 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0059 PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORP] 3 Current NDC, 2 package rows 20250525_69934bbb-922c-4752-b253-f2f07340de8d.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 17856-0059-1 17856005901 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0059-1) / 5 mL in 1 CUP, UNIT-DOSE 2023-11-13 No No Current