Home NDC 17856-4023 PROMETHAZINE HYDROCHLORIDE
Product NDC 17856-4023
11-digit product format 178564023
Labeler code 17856
Product ID 17856-4023_4f99bbe0-279d-da57-e063-6294a90ab362
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name promethazine hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Atlantic Biologicals Corp.
Application ANDA087953
Marketing category ANDA
Marketing start 2025-04-07
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 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 A087953-001 PROMETHAZINE PLAIN PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A087953-001 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 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RS 1982-11-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087953-001 PROMETHAZINE PLAIN 6.25MG/5ML SYRUP / ORAL AA RLD, RS 1982-11-15 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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-4023-1 PROMETHAZINE HYDROCHLORIDE 72 in 1 CASE SYRUP 72 1 17856-4023-1 PROMETHAZINE HYDROCHLORIDE 5 mL in 1 CUP, UNIT-DOSE SYRUP 5 1
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 Marketing start Sample Exclude flag Status 17856-4023-1 17856402301 72 CUP, UNIT-DOSE in 1 CASE (17856-4023-1) / 5 mL in 1 CUP, UNIT-DOSE 2026-04-20 No No Current