NDC codes

FDA NDC Directory
Product NDC (as listed)16714-445Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0445Add 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 NDC11-digit (billing)PackageCopy
16714-445-011671404450116714044501100 TABLET in 1 BOTTLE (16714-445-01)Marketed from Aug 6, 2015
16714-445-0216714044502167140445021000 TABLET in 1 BOTTLE (16714-445-02)Marketed from Aug 6, 2015

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)
Enalapril Maleate
Generic name (nonproprietary)
enalapril maleate
Active ingredients
Enalapril maleate — 20 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Northstar RxLLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075459
Marketing start
Listing expires
Other FDA classes
Angiotensin-converting Enzyme Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)
Identifiers
Product ID 16714-445_4bc84994-0116-425c-8dab-ba08b0880b24SPL ID 4bc84994-0116-425c-8dab-ba08b0880b24SPL set ID e109e7b1-4650-4416-9d89-7c1185d5cf48RxCUI 858804, 858810, 858813, 858817UNII 9O25354EPJUPC 0316714445014, 0316714443010

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

N416714044501 followed by a unit qualifier and the quantity

Package 16714-0445-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hypertension Enalapril maleate tablets, USP are indicated for the treatment of hypertension. Enalapril maleate tablets, USP are effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. Heart Failure Enalapril maleate tablets, USP are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16714-445

What is NDC 16714-445?
16714-445 is the product NDC for Enalapril Maleate, Enalapril maleate 20 mg/1 tablet, listed with the FDA by Northstar RxLLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Enalapril Maleate.
What is the active ingredient?
Enalapril maleate.
Who is the labeler?
Northstar RxLLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Enalapril Maleate?
97 other product NDCs are listed under this name. See all Enalapril Maleate 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 Enalapril Maleate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Enalapril MaleateEnalapril maleate 2.5 mg/1TabletOralCoupler LLC67046-125467046-1254-03
Enalapril MaleateEnalapril maleate 5 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-416468788-4164-0168788-4164-0368788-4164-06+1 more
Enalapril MaleateEnalapril maleate 20 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-414768788-4147-0068788-4147-0368788-4147-06+1 more
Enalapril MaleateEnalapril maleate 10 mg/1TabletOralCoupler LLC67046-079867046-0798-03
Enalapril MaleateEnalapril maleate 10 mg/1TabletOralAmici Pharma, Inc69292-54469292-0544-0169292-0544-1069292-0544-50
Enalapril MaleateEnalapril maleate 2.5 mg/1TabletOralAmici Pharma, Inc69292-54069292-0540-0169292-0540-10
Enalapril MaleateEnalapril maleate 5 mg/1TabletOralAmici Pharma, Inc69292-54269292-0542-0169292-0542-1069292-0542-50
Enalapril MaleateEnalapril maleate 20 mg/1TabletOralAmici Pharma, Inc69292-54669292-0546-0169292-0546-10
Enalapril maleateEnalapril maleate 2.5 mg/1TabletOralMajor Pharmaceuticals0904-730900904-7309-61
Enalapril maleateEnalapril maleate 5 mg/1TabletOralMajor Pharmaceuticals0904-731000904-7310-61

All 98 Enalapril Maleate NDCs

Other NDCs under ANDA 075459

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

FDA NDC Directory listings under ANDA 075459
ProductStrengthForm · routeLabelerProduct NDC
Enalapril MaleateEnalapril maleate 10 mg/1TabletOralNorthstar RxLLC16714-444

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