What is NDC 69315-133?

69315-133 is the product NDC for Imipramine Hydrochloride, Imipramine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Leading Pharma, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Leading Pharma, LLC, NDC labeler code 69315. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Imipramine Hydrochloride?

30 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Imipramine Hydrochloride NDC 69315-133

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-133Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0133Add 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	Copy
69315-133-01	69315013301	100 TABLET, FILM COATED in 1 BOTTLE (69315-133-01)Marketed from Apr 7, 2016
69315-133-10	69315013310	1000 TABLET, FILM COATED in 1 BOTTLE (69315-133-10)Marketed from Apr 14, 2016

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Imipramine Hydrochloride
Generic name (nonproprietary): imipramine hydrochloride
Active ingredients: Imipramine hydrochloride — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Leading Pharma, LLCNDC labeler code 69315
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040903
Marketing start: Apr 7, 2016
Listing expires: Dec 31, 2027
Identifiers: Product ID 69315-133_228e6710-c359-4091-aca0-3d0c68ae706bSPL ID 228e6710-c359-4091-aca0-3d0c68ae706bSPL set ID 490263ce-b4d2-428a-87da-fcd07f85499aRxCUI 835564, 835568, 835593UNII BKE5Q1J60U
Pharmacologic class: Tricyclic Antidepressant

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

N469315013301 followed by a unit qualifier and the quantity

Package 69315-0133-01. 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 11, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Depression - For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Childhood Enuresis - May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69315-133

What is NDC 69315-133?: 69315-133 is the product NDC for Imipramine Hydrochloride, Imipramine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Leading Pharma, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Imipramine Hydrochloride.
What is the active ingredient?: Imipramine hydrochloride.
Who is the labeler?: Leading Pharma, LLC, NDC labeler code 69315. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Imipramine Hydrochloride?: 30 other product NDCs are listed under this name. See all Imipramine 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 Imipramine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Imipramine Hydrochloride	Imipramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1564	67046-1564-03
Imipramine Hydrochloride	Imipramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0342	80425-0342-0180425-0342-0280425-0342-03
Imipramine hydrochloride	Imipramine hydrochloride 10 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0294	80425-0294-0180425-0294-0280425-0294-03
Imipramine Hydrochloride	Imipramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Key Therapeutics	70868-810	70868-0810-10
Imipramine Hydrochloride	Imipramine hydrochloride 25 mg/1	TabletOral	Strides Pharma Science Limited	64380-170	64380-0170-0164380-0170-02
Imipramine Hydrochloride	Imipramine hydrochloride 10 mg/1	TabletOral	Strides Pharma Science Limited	64380-169	64380-0169-0164380-0169-02
Imipramine Hydrochloride	Imipramine hydrochloride 50 mg/1	TabletOral	Strides Pharma Science Limited	64380-171	64380-0171-0164380-0171-02
Imipramine Hydrochloride	Imipramine hydrochloride 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-3526	70518-3526-0070518-3526-0170518-3526-03
Imipramine Hydrochloride	Imipramine hydrochloride 50 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-244	72789-0244-01
Imipramine Hydrochloride	Imipramine hydrochloride 10 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-240	72789-0240-0172789-0240-95

All 31 Imipramine Hydrochloride NDCs

Other NDCs under ANDA 040903

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

FDA NDC Directory listings under ANDA 040903
Product	Strength	Form · route	Labeler	Product NDC
Imipramine Hydrochloride	Imipramine hydrochloride 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1588
Imipramine Hydrochloride	Imipramine hydrochloride 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-804
Imipramine Hydrochloride	Imipramine hydrochloride 50 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-493
Imipramine Hydrochloride	Imipramine hydrochloride 25 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-492
Imipramine Hydrochloride	Imipramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2601
Imipramine Hydrochloride	Imipramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Leading Pharma, LLC	69315-134
Imipramine Hydrochloride	Imipramine hydrochloride 50 mg/1	Tablet, Film coatedOral	Leading Pharma, LLC	69315-135
Imipramine Hydrochloride	Imipramine hydrochloride 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3106
Imipramine Hydrochloride	Imipramine hydrochloride 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3148
Imipramine hydrochloride	Imipramine hydrochloride 10 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0294
Imipramine Hydrochloride	Imipramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1564