What is NDC 71335-1139?

71335-1139 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 25 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Promethazine Hydrochloride?

114 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Promethazine Hydrochloride NDC 71335-1139

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1139Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1139Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
71335-1139-0	71335113900	14 TABLET in 1 BOTTLE (71335-1139-0)Marketed from Apr 3, 2024
71335-1139-1	71335113901	15 TABLET in 1 BOTTLE (71335-1139-1)Marketed from Nov 1, 2019
71335-1139-2	71335113902	30 TABLET in 1 BOTTLE (71335-1139-2)Marketed from Mar 6, 2019
71335-1139-3	71335113903	10 TABLET in 1 BOTTLE (71335-1139-3)Marketed from Mar 14, 2019
71335-1139-4	71335113904	20 TABLET in 1 BOTTLE (71335-1139-4)Marketed from Mar 19, 2019
71335-1139-5	71335113905	12 TABLET in 1 BOTTLE (71335-1139-5)Marketed from Mar 26, 2019
71335-1139-6	71335113906	60 TABLET in 1 BOTTLE (71335-1139-6)Marketed from Apr 12, 2019
71335-1139-7	71335113907	90 TABLET in 1 BOTTLE (71335-1139-7)Marketed from Jun 3, 2019
71335-1139-8	71335113908	6 TABLET in 1 BOTTLE (71335-1139-8)Marketed from Oct 4, 2019
71335-1139-9	71335113909	56 TABLET in 1 BOTTLE (71335-1139-9)Marketed from Apr 17, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Promethazine Hydrochloride
Generic name (nonproprietary): promethazine hydrochloride
Active ingredients: Promethazine hydrochloride — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040596
Marketing start: Dec 14, 2005
Listing expires: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 71335-1139_b02527e6-b912-4a80-8d6a-a78a7685dc55SPL ID b02527e6-b912-4a80-8d6a-a78a7685dc55SPL set ID ea490539-007b-47b1-bef9-22de02ae7c64RxCUI 992447UNII R61ZEH7I1I
Pharmacologic class: Phenothiazine

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N471335113900 followed by a unit qualifier and the quantity

Package 71335-1139-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Aug 8, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Promethazine Hydrochloride, is useful orally for. Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for co…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1139

What is NDC 71335-1139?: 71335-1139 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 25 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Promethazine Hydrochloride.
What is the active ingredient?: Promethazine hydrochloride.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Promethazine Hydrochloride?: 114 other product NDCs are listed under this name. See all Promethazine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Promethazine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Northwind Health Company, LLC	82868-115	82868-0115-20
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Coupler LLC	67046-1043	67046-1043-03
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-070	87441-0070-01
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1854	00121-1854-16
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-4419	70518-4419-00
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SyrupOral	Xttrium Laboratories, Inc.	0116-4023	00116-4023-16
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SyrupOral	Atlantic Biologicals Corp.	17856-4023	17856-4023-01
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/1	TabletOral	Coupler LLC	67046-1447	67046-1447-03
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SolutionOral	Kesin Pharma Corporation	81033-016	81033-0016-50
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Cardinal Health 107, LLC	55154-3373	55154-3373-00

All 115 Promethazine Hydrochloride NDCs

Other NDCs under ANDA 040596

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 040596
Product	Strength	Form · route	Labeler	Product NDC
Phenerganpromethazine hcl	Promethazine hydrochloride 12.5 mg/1	TabletOral	Direct_Rx	72189-402
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/1	TabletOral	Coupler LLC	67046-1447
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	American Health Packaging	68084-155
Promethazine Hydrochloride	Promethazine hydrochloride 12.5 mg/1	TabletOral	Asclemed USA, Inc.	76420-678
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Asclemed USA, Inc.	76420-679
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/1	TabletOral	Asclemed USA, Inc.	76420-692
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0265
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Proficient Rx LP	71205-658
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	DIRECT RX	72189-176
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-1306
Promethazine Hydrochloride	Promethazine hydrochloride 12.5 mg/1	TabletOral	REMEDYREPACK INC.	70518-2488
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8154
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/1	TabletOral	BluePoint Laboratories	68001-163
Promethazine Hydrochloride	Promethazine hydrochloride 12.5 mg/1	TabletOral	BluePoint Laboratories	68001-161
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	BluePoint Laboratories	68001-162
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4809
Promethazine Hydrochloride	Promethazine hydrochloride 12.5 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-040
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-041
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-042
Promethazine Hydrochloride	Promethazine hydrochloride 12.5 mg/1	TabletOral	American Health Packaging	60687-660

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