Home NDC 62135-774-23 PROMETHAZINE HYDROCHLORIDE
Product NDC 62135-774
Requested package NDC 62135-774-23
11-digit product format 621350774
Labeler code 62135
Product ID 62135-774_499ebc74-646b-4e6d-e063-6394a90ab998
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PROMETHAZINE HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA040026
Marketing category ANDA
Marketing start 1998-09-25
Substance PROMETHAZINE HYDROCHLORIDE
Active strength 6.25 mg/5mL
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 62135-774 62135-774-23 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A040026-001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040026-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040026-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 1998-09-25 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base PROMETHAZINE HYDROCHLORIDE
Listing expiration 2027-12-31 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# NDC, Effective, Related label table NDC Effective Related label 62135-774-23 2025-09-30 PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP 62135-774-24 2025-09-30 PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP 62135-774-41 2025-09-30 PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP 62135-774-47 2025-09-30 PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP 62135-774-23 2025-07-29 PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP 62135-774-24 2025-07-29 PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP 62135-774-41 2025-07-29 PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP 62135-774-47 2025-07-29 PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-774-05 PROMETHAZINE HYDROCHLORIDE 5 mL in 1 CUP SOLUTION 5 4 62135-774-10 PROMETHAZINE HYDROCHLORIDE 10 mL in 1 CUP SOLUTION 10 4 62135-774-23 PROMETHAZINE HYDROCHLORIDE 2 in 1 BOX SOLUTION 2 4 62135-774-23 PROMETHAZINE HYDROCHLORIDE 10 in 1 TRAY SOLUTION 10 4 62135-774-24 PROMETHAZINE HYDROCHLORIDE 10 in 1 TRAY SOLUTION 10 4 62135-774-24 PROMETHAZINE HYDROCHLORIDE 2 in 1 BOX SOLUTION 2 4 62135-774-41 PROMETHAZINE HYDROCHLORIDE 120 mL in 1 BOTTLE SOLUTION 120 4 62135-774-47 PROMETHAZINE HYDROCHLORIDE 473 mL in 1 BOTTLE SOLUTION 473 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-774 PROMETHAZINE HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC] 2 Current NDC, 8 package rows 20250215_2ca17cd4-460e-4d54-8c53-a58a2b80e5cb.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62135-774-23 62135077423 2 TRAY in 1 BOX (62135-774-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-774-10) 2 tray 2025-02-10 No No Current